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1.
Eur J Ophthalmol ; : 11206721241235700, 2024 Mar 11.
Article in English | MEDLINE | ID: mdl-38462930

ABSTRACT

OBJECTIVE: To assess the effectiveness and safety of a rigorous short-term supine position in preventing inadvertent retinal displacement after pars plana vitrectomy (PPV) with gas tamponade for rhegmatogenous retinal detachment (RRD). METHODS: We conducted a retrospective observational analysis of a case series at two ophthalmological surgical centers. We included eyes diagnosed with macula-off RRD that maintained a strict face-up position for three hours immediately after PPV with intraoperative perfluorocarbon liquid (PFCL) and 20% sulfur hexafluoride (SF6) tamponade. Fundus autofluorescence (FAF) imaging was performed at one month post-operatively to identify unintentional retinal displacement through the detection of retinal vessel prints (RVPs) on FAF imaging using an ultrawide-field (UWF) imaging system. RESULTS: A total of 29 eyes with macula-off RRD were included in the study. The average age of the participants was 59.62 years. RRD involved one quadrant in two eyes, two quadrants in fourteen eyes, three quadrants in seven eyes, and four quadrants in six eyes. UWF-FAF imaging at one month follow-up after complete reattachment of the retina revealed RVPs in seven out of the 29 eyes (24.13%), with a mean displacement of 0.22 mm. In every case the displacement occurred downward. CONCLUSION: Our results suggest that adhering to a strict face-up position for three hours after PPV with PFCL and gas tamponade for macula-off RRD may lead to a low frequency and severity of inadvertent post-operative retinal displacement.

2.
Ophthalmology ; 130(9): 947-957, 2023 09.
Article in English | MEDLINE | ID: mdl-37088447

ABSTRACT

PURPOSE: To compare the efficacy and the safety of submacular hemorrhage (SMH) management using either surgical pars plana vitrectomy (PPV) or pneumatic displacement (PD) with tissue plasminogen activator (tPA) and vascular endothelial growth factor (VEGF) inhibitor added to each arm. DESIGN: Randomized, open-label, multicenter superiority study. PARTICIPANTS: Ninety patients with neovascular age-related macular degeneration (nAMD) 50 years of age or older with recent SMH (≤ 14 days) of more than 2 optic disc areas and predominantly overlying the retinal pigment epithelium. METHODS: Patients were assigned randomly to surgery (PPV, subretinal tPA [maximum, 0.5 ml/50 µg], and 20% sulfur hexafluoride [SF6] tamponade) or PD (0.05 ml intravitreal tPA [50 µg] and 0.3 ml intravitreal pure SF6). Both groups were asked to maintain a head upright position with the face forward at 45° for 3 days after intervention and received 0.5 mg intravitreal ranibizumab at the end of the intervention, at months 1 and 2, as the loading phase, and then on a pro re nata regimen during a 6-month follow-up. MAIN OUTCOME MEASURES: The primary efficacy endpoint was mean best-corrected visual acuity (VA) change at month 3. The secondary endpoints were mean VA change at month 6, 25-item National Eye Institute Visual Function Questionnaire composite score value at months 3 and 6, number of anti-VEGF injections, and complications during the 6-month follow-up. RESULTS: Of the 90 patients randomized, 78 patients (86.7%) completed the 3-month efficacy endpoint visit. The mean VA change from baseline to month 3 in the surgery group (+16.8 letters [95% confidence interval (CI), 8.7-24.9 letters]) was not significantly superior to that in the PD group (+16.4 letters [95% CI, 7.1-25.7 letters]; adjusted difference ß, 1.9 [-11.0; 14.9]; P = 0.767). Both groups achieved similar secondary outcomes at month 6. No unexpected ocular safety concerns were observed in either group. CONCLUSIONS: Surgery did not yield superior visual gain nor additional benefit for SMH secondary to nAMD compared with PD at 3 months, with intravitreal anti-VEGF added to each arm. Both treatment strategies lead to a clinical improvement of VA without safety concerns for SMH over 6 months. Both design and results of the trial cannot be used to establish equivalence between treatments. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.


Subject(s)
Macular Degeneration , Tissue Plasminogen Activator , Humans , Middle Aged , Infant, Newborn , Tissue Plasminogen Activator/therapeutic use , Angiogenesis Inhibitors/therapeutic use , Fibrinolytic Agents/therapeutic use , Vascular Endothelial Growth Factor A , Ranibizumab/therapeutic use , Retinal Hemorrhage/drug therapy , Retinal Hemorrhage/etiology , Retinal Hemorrhage/surgery , Macular Degeneration/complications , Macular Degeneration/drug therapy , Retinal Pigment Epithelium , Intravitreal Injections
3.
Ophthalmic Res ; 66(1): 824-834, 2023.
Article in English | MEDLINE | ID: mdl-36972579

ABSTRACT

INTRODUCTION: Information about real-world ranibizumab use is needed to optimize treatment of macular edema secondary to retinal vein occlusion (RVO). The BOREAL-RVO study assessed treatment use, effectiveness, and safety of 24-month treatment with ranibizumab 0.5 mg in patients with visual impairment due to macular edema secondary to RVO in a real-world setting. METHODS: This was a multicenter, post-authorization, observational study in France, including patients starting ranibizumab for RVO. Primary endpoint was mean change from baseline in best-corrected visual acuity (BCVA) at month 6. Secondary endpoints were mean changes from baseline in BCVA at month 24 and central retinal thickness (CRT) at months 6 and 24, and treatment use in real-world setting. RESULTS: 226 branch RVO (BRVO) and 196 central RVO (CRVO) patients were enrolled; 71.7% and 70.9% completed the 24-month follow-up, respectively. In BRVO, mean (SD) baseline BCVA was 55.2 (18.7) letters, with gains of 14.3 (13.7), 14.1 (16.5), 13.0 (17.5), and 11.4 (20.1) letters at months 3, 6, 12, and 24, respectively. In CRVO, mean (SD) baseline BCVA was 40.4 (25.6) letters, with gains of 16.0 (21.2), 9.5 (25.4), 9.2 (27.7), and 8.3 (23.8) letters at months 3, 6, 12, and 24, respectively. At month 24, 52% of BRVO and 41% of CRVO patients had gains of 15 or more letters. In BRVO, mean (SD) CRT values at baseline and months 3, 6, 12, and 24 were 550 (175), 315 (104), 343 (122), 335 (137), and 340 (105) µm. In CRVO, mean (SD) CRT values at baseline and months 3, 6, 12, and 24 were 643 (217), 327 (152), 400 (203), 379 (175), and 348 (161) µm. On average, BRVO patients had 3.8 injections for 6.9 visits by month 6, and 7.2 injections for 19.7 visits by month 24. CRVO patients had 2.7 injections for 4.2 visits by month 6 and 7.1 injections for 21.1 visits by month 24. Factors predictive of better BCVA gain at month 6 were age under 60 at baseline, lower baseline BCVA and BCVA gain at month 3. There were no new safety findings. CONCLUSION: Major improvements in BCVA and CRT were observed at month 3 after the induction phase and then were sustained up to month 24, with a slight decrease, probably due to under-treatment. This study demonstrated ranibizumab to be a safe and effective treatment for BRVO and CRVO in the real-world setting, although more regular or proactive treatment could further improve outcomes.


Subject(s)
Macular Edema , Retinal Vein Occlusion , Humans , Ranibizumab/therapeutic use , Retinal Vein Occlusion/complications , Retinal Vein Occlusion/diagnosis , Retinal Vein Occlusion/drug therapy , Macular Edema/diagnosis , Macular Edema/drug therapy , Macular Edema/etiology , Angiogenesis Inhibitors/therapeutic use , Intravitreal Injections , Visual Acuity , Tomography, Optical Coherence , Treatment Outcome , Vision Disorders/drug therapy , Follow-Up Studies
4.
Retina ; 43(4): 581-584, 2023 04 01.
Article in English | MEDLINE | ID: mdl-36727989

ABSTRACT

PURPOSE: To report on results of pars plana vitrectomy with ILM peeling in patients with rhegmatogenous retinal detachment (RRD) and concomitant macular hole (MH) and to assess for preoperative associated conditions related to this type of RRD. METHODS: Patients undergoing surgical repair for RRD between 2014 and 2021 were reviewed, and subjects with concomitant, non-causal, macular hole were identified. We studied post-operative macular status, retinal reattachment rate and visual acuity. RESULTS: Over 532 eyes operated on for RRD, 11 (2.06%) had a concurrent non-causal macular hole. Preoperative PVR B or superior was recorded in 86 eyes (16.6%) of the entire cohort and in 6 eyes (54.54 %) with RRD and concomitant MH (p=0.00001). Severe hypotony with choroidal detachment was present in 15 eyes (2.81%) of the entire cohort and in 3 eyes (27.27%) with RRD and concomitant MH (p=<0.00001). CONCLUSIONS: RRD with concomitant MH is an infrequent association. Retinal reattachment and anatomical hole closure can be achieved in most of cases but despite this fact, functional recovery is usually not good. Preoperative PVR is a more frequent finding in this group of patients, as well as severe hypotony with choroidal detachment.


Subject(s)
Retinal Detachment , Retinal Perforations , Humans , Retinal Detachment/diagnosis , Retinal Detachment/surgery , Retinal Detachment/complications , Retinal Perforations/complications , Retinal Perforations/surgery , Vitrectomy/methods , Tomography, Optical Coherence , Retina , Retrospective Studies
5.
Eur J Ophthalmol ; 33(3): 1361-1366, 2023 May.
Article in English | MEDLINE | ID: mdl-36464664

ABSTRACT

PURPOSE: The lens-iris diaphragm retropulsion syndrome (LIDRS) corresponds to an acute deepening of the anterior chamber during phacoemulsification. LIDRS is painful for the patient and sometimes causes intraoperative complications. This study was designed to assess the preoperative risk factors of LIDRS and its outcome. SETTING: Monocentric study in the university department of ophthalmology, Intercommunal Hospital Center, Creteil, France. DESIGN: Prospective observational study. METHODS: Preoperative parameters of consecutive patients who underwent cataract surgery were recorded. LIDRS occurrence was evaluated during surgery and classified into 3 stages. Except for the first patient, a simple and rapid maneuver to separate the iris from the capsule was performed in all patients with LIDRS. RESULTS: LIDRS occurred in 101 out of 205 included eyes: mild in 73.2%, marked in 16.8%, and severe in 9.9%. LIDRS patients were younger, and had a longer axial length and a thinner lens than the control group (p < 0.01 for all). Univariate logistic regression showed that the main predictive factors of LIDRS were long axial length and decreased lens thickness. LIDRS occurred in 83% (5/6) of eyes with prior vitrectomy. Complications occurred (zonular dehiscence, lens or IOL dislocation), especially in vitrectomized eyes. The maneuver separating the iris from the capsule allowed almost all eyes to restore normal chamber depth and prevent complications. CONCLUSIONS: Myopia and prior vitrectomy were the main risk factors of LIDRS. The maneuver separating the iris from the capsule allowed almost all eyes to resolve LIDRS. Analysis of preoperative factors can help the surgeon identify patients at risk and prevent patient pain and intraoperative complications associated with LIDRS.


Subject(s)
Cataract Extraction , Phacoemulsification , Humans , Prospective Studies , Iris , Cataract Extraction/adverse effects , Phacoemulsification/adverse effects , Syndrome , Risk Factors , Vitrectomy , Intraoperative Complications/epidemiology , Intraoperative Complications/etiology , Pain/etiology , Postoperative Complications/etiology
6.
Eur J Ophthalmol ; 32(1): 539-545, 2022 Jan.
Article in English | MEDLINE | ID: mdl-33626933

ABSTRACT

PURPOSE: To evaluate anatomical and functional changes in patients with vitreomacular interface disease after internal limiting membrane (ILM) peeling, using microperimetry along with usual clinical and multimodal retinal imaging. METHODS: Patients with vitreomacular interface disease requiring vitrectomy underwent multimodal retinal evaluation, including visual acuity assessment, fundus color photograph, Spectral-Domain Optical Coherence Tomography, Optical Coherence Tomography-Angiography, and microperimetry. They were examined at baseline (M0), 6 months (M6) and 18 months (M18) after surgery. Retinal sensitivity was subdivided into three concentric polygons: Large, Medium, Small. RESULTS: Eleven eyes of 11 patients were analyzed, including 10 epiretinal membranes (ERMs). Best-corrected visual acuity (BCVA) improved in all patients from 0.51 logarithm of the minimal angle of resolution (logMAR) to 0.067 (p = 0.0074). Retinal sensitivity improved between M0 and M6 in all polygons and continued to improve between M6 and M18 for polygons Medium (M) and Small (S) with no statistical significance. At M18, BCVA and retinal sensitivity were similar in the operated eye compared with the fellow eye for all patients. Dissociated optic nerve fiber layer appearance was observed in 8 patients at M18. It was not correlated with either retinal sensitivity or BCVA or microscotomas. No recurrence of ERM or macular hole occurred during follow-up. CONCLUSION: After surgery, the retinal sensitivity assessed by microperimetry gradually improved until the 18th month and was not different from the values of the fellow eye. These results seemed to confirm that ILM peeling can be an effective and safe technique to treat patients with vitreomacular interface disease.


Subject(s)
Epiretinal Membrane , Retinal Perforations , Basement Membrane/surgery , Epiretinal Membrane/surgery , Follow-Up Studies , Humans , Retina/diagnostic imaging , Retinal Perforations/surgery , Retrospective Studies , Tomography, Optical Coherence , Visual Field Tests , Vitrectomy
7.
Graefes Arch Clin Exp Ophthalmol ; 259(8): 2139-2147, 2021 Aug.
Article in English | MEDLINE | ID: mdl-33625565

ABSTRACT

PURPOSE: To describe the structural changes observed postoperatively in epiretinal membranes (ERM), in particular the alterations in the central cone bouquet (CB), and to identify prognostic factors that might predict postoperative outcome. METHODS: We included 125 eyes of 117 patients who underwent idiopathic ERM removal with at least a 6-month follow-up. For each patient, spectral-domain optical coherence tomography (SD-OCT) was performed and best-corrected visual acuity (BCVA) was measured, before and after surgery. RESULTS: Before surgery, 44 eyes (35.2%) presented CB alterations: 65.9% a cotton ball sign, 15.9% a foveolar detachment and 18.2% a pseudovitelliform lesion. Median BCVA increased from 20/63 to 20/32 post-operatively (p = .001) with a mean follow-up of 17 months. The disappearance of CB alterations after surgery was observed in 97.7% of eyes. In stage 3 and 4 ERM, ectopic inner foveal layers persisted in 76.7% of eyes after surgery. Postoperative BCVA was correlated with change in central macular thickness and initial BCVA and was not correlated with the presence of preoperative CB alteration, the initial stage of ERM, the presence of postoperative dissociated optical nerve fiber layer, and the disappearance of ectopic inner fiber layers. The combination of cataract surgery and capsulotomy did not seem to change visual outcome and seemed to accelerate visual recovery. Incidentally, general anesthesia was correlated with final BCVA. CONCLUSION: ERM surgery allowed a significant gain in BCVA and the disappearance of CB alterations in the great majority of cases. CB alteration did not show to be associated with poor visual prognosis.


Subject(s)
Epiretinal Membrane , Epiretinal Membrane/diagnosis , Epiretinal Membrane/surgery , Follow-Up Studies , Humans , Prognosis , Retrospective Studies , Tomography, Optical Coherence , Visual Acuity , Vitrectomy
8.
Ophthalmic Res ; 64(4): 577-586, 2021.
Article in English | MEDLINE | ID: mdl-32932257

ABSTRACT

PURPOSE: To assess the efficacy, safety, and follow-up of 36-month treatment with ranibizumab in patients with diabetic macular edema (DME) in real-life setting. METHODS: This is a prospective phase 4 observational study. Between December 2013 and April 2015, 84 ophthalmologists enrolled a total of 290 adult patients initiating ranibizumab for visual impairment due to DME and treated them according to their routine practice. The primary outcome (mean change in best-corrected visual acuity [BCVA] after 12 months) was previously reported. Here, we present outcomes after 36 months of follow-up for BCVA and change in central subfield thickness (CSFT) and report how participating ophthalmologists treated DME over a 3-year period (number of visits and injections and evolution of treatment strategy). RESULTS: Of the 290 patients enrolled, 187 (64.5%) completed the 36 months of the study (entire cohort). In the entire cohort, 97 patients were treated exclusively with ranibizumab throughout the study, and 90 patients switched to other intravitreal treatments. Mean BCVA was 64.2 (20.1) letters, representing a gain of +4.1 (19.9) letters from baseline to month 36 (M36). CSFT improved over the study, and by M36 had decreased by 127 (138) µm compared to baseline. Over the 36 months of follow-up, patients in the entire cohort paid their ophthalmologists a mean of 30.9 (12.2) visits and had a mean of 7.6 (5.2) any injections. Results for quality of life questionnaires NEI-VFQ25 and HUI-3 remained stable throughout the study. Multivariate analysis on the 145 patients with evaluable BCVA data at M36 found that male gender and milder baseline DME characteristics (BCVA ≥59 and CSFT <500 µm) were predictive factors for achieving a BCVA of ≥70 letters at M36. This study did not find any new safety signals, compared to the known profile of ranibizumab. CONCLUSIONS: Gains in BCVA in this real-life study were lower than those observed in randomized clinical trials with ranibizumab, mainly due to undertreatment. Safety analysis of ranibizumab did not yield any new safety concerns.


Subject(s)
Diabetes Mellitus , Diabetic Retinopathy , Macular Edema , Adult , Angiogenesis Inhibitors/therapeutic use , Diabetes Mellitus/drug therapy , Diabetic Retinopathy/complications , Diabetic Retinopathy/diagnosis , Diabetic Retinopathy/drug therapy , Humans , Intravitreal Injections , Macular Edema/diagnosis , Macular Edema/drug therapy , Macular Edema/etiology , Male , Prospective Studies , Quality of Life , Ranibizumab/therapeutic use , Tomography, Optical Coherence , Vascular Endothelial Growth Factor A , Vision Disorders/diagnosis , Vision Disorders/drug therapy , Vision Disorders/etiology , Visual Acuity
9.
J Asthma ; 58(5): 573-585, 2021 05.
Article in English | MEDLINE | ID: mdl-31958254

ABSTRACT

Objective. Asthma is a chronic inflammatory airway disorder known to induce small airways dysfunction (SAD). It is important to develop tools to assess the presence and extent of SAD in daily clinical practice. An Impulse Oscillometry System (IOS) might detect SAD, but the validity of the underlying model (serial Resistive airway and Compliant tissue model: RC model) in diseased lungs remains questionable.Methods. Our objective was to evaluate the usefulness of parameters obtained from six electrical circuit models that were fitted to the measurements of impedance obtained with IOS in asthmatic children characterized by an abnormal lung function defined by an increased baseline interrupter resistance (Rint, z-score > +1.645).Results. The six models were tested in 102 asthmatic children (median age: 5.5 years). Two models allowed the description of 92/102 (90%) children: 74 by the extended RIC model (central and peripheral Resistance, Inertance and peripheral airway Compliance) and 18 by the Mead1969 model (extended RIC plus lung compliance). Thus, peripheral airway compliance and resistance were essential to describe lung function abnormalities of these asthmatic children. Parenchyma impairment (increased lung compliance) which was responsive to salbutamol was present in 18% of asthmatic children. After salbutamol, peripheral airway resistance decreased while peripheral airway compliance increased, arguing for asthma-related SAD. R5-20Hz independently correlated with the two latter parameters but was increased in two thirds of children with increased Rint only.Conclusion. Additional modeling of IOS results can be a reliable tool to assess the presence and extent of SAD in young asthmatic children.


Subject(s)
Asthma/physiopathology , Lung/physiopathology , Models, Biological , Airway Resistance , Albuterol/pharmacology , Bronchodilator Agents/pharmacology , Child , Child, Preschool , Female , Humans , Lung Compliance , Male , Oscillometry , Phenotype
10.
Retina ; 41(6): 1202-1209, 2021 Jun 01.
Article in English | MEDLINE | ID: mdl-33105298

ABSTRACT

PURPOSE: To compare widefield optical coherence tomography angiography (OCTA) to ultra-widefield fluorescein angiography (UWFA) in the assessment of nonperfusion in retinal vein occlusion (RVO). METHODS: A cross-sectional study of 43 eyes of 43 patients with RVO examined using both widefield OCTA (PLEX Elite, Carl Zeiss Meditec, Dublin, CA) with a panoramic montage of five 12 × 12-mm images and UWFA (Optos, 200°). Qualitative analysis was performed according to nonperfusion areas (cutoff: three disk areas) on widefield OCTA. The quantitative analysis assessed the vascular density on the widefield OCTA and ischemic index on UWFA. RESULTS: The ischemic index on UWFA and vascular density in the superficial and deep plexus correlated significantly (P = 0.019, r = 0.357 and P < 0.013, r = 0.375, respectively). The qualitative classification on widefield OCTA and ischemic index on UWFA correlated significantly (P < 0.001, r = 0.618). For the detection of marked nonperfusion (ischemic index ≥ 25%), widefield OCTA had a sensitivity of 100% and a specificity of 64.9%. CONCLUSION: The presence of nonperfusion on UWFA correlated with widefield OCTA. Optical coherence tomography angiography could help to identify high-risk RVO patients who might benefit from a further evaluation using fluorescein angiography.


Subject(s)
Fluorescein Angiography/methods , Retinal Vein Occlusion/diagnosis , Retinal Vein/diagnostic imaging , Tomography, Optical Coherence/methods , Visual Acuity , Aged , Cross-Sectional Studies , Female , Fundus Oculi , Humans , Male , ROC Curve
11.
Transl Vis Sci Technol ; 8(3): 7, 2019 May.
Article in English | MEDLINE | ID: mdl-31110909

ABSTRACT

PURPOSE: To study the association between the assessment of central macular vascular layers by optical coherence tomography angiography (OCT-A) and peripheral nonperfusion evaluated by fluorescein angiography (FA) in patients with retinal venous occlusion (RVO). METHODS: Retrospective review of RVO patients without macular edema. Patients underwent a comprehensive ophthalmic examination including FA, spectral-domain OCT, and OCT-A. Significant ischemia was defined as nonperfusion areas superior or equal to the equivalent of one retinal quadrant on FA. Vascular density (VD) and foveal avascular zone were measured using AngioAnalytics software. Fractal dimension (FD) and lacunarity (LAC) were computed using an algorithm designed by MATLAB (MathWorks, Natick, MA). These variables were used to build a model that translates their association with OCT-A parameters. RESULTS: There were 48 eyes (48 patients) of which 19 had significant peripheral nonperfusion. Deep capillary plexus FD, VD, and LAC were associated with significant ischemia. In fact, regarding the association with this outcome, LAC alone had the highest area under the curve (AUC = 0.88) followed by FD (AUC = 0.85) and VD (AUC = 0.73). The multivariable model that included LAC and VD, adjusted by best-corrected visual acuity (BCVA) achieved the best performance for the identification of severe nonperfusion on wide-field FA (AUC = 0.93). CONCLUSIONS: The characteristics of the central macular deep capillary plexus on OCT-A may be associated with peripheral nonperfusion on FA, particularly the combination of LAC and vessel density after adjusting by BCVA. TRANSLATIONAL RELEVANCE: Fractal-based metrics applied to OCT-A may become a valuable marker of ischemia in RVO and help guide the clinical decision to perform invasive angiography.

12.
Ophthalmic Res ; 62(2): 101-110, 2019.
Article in English | MEDLINE | ID: mdl-30928985

ABSTRACT

PURPOSE: To report the real-world effectiveness and safety of ranibizumab 0.5 mg in patients with visual impairment due to diabetic macular edema (DME). METHODS: This is a French, 36-month, multicenter, observational cohort study. Between December 2013 and April 2015, ophthalmologists enrolled diabetic patients aged ≥18 years with DME-related visual impairment and for whom ranibizumab 0.5 mg was initiated. Here, we present the 12-month results from this cohort. The primary endpoint was the mean change in best-corrected visual acuity (BCVA); sample size calculations were based on RESTORE trial data (BCVA mean change = 6.8 letters, preci sion = 0.7 letters). Secondary endpoints included the change in central subfield thickness (CSFT), number of visits, number of injections received, and frequency of ocular and nonocular adverse events and serious adverse events. RESULTS: Between December 2013 and April 2015, a total of 290 patients with DME were enrolled by 84 ophthalmologists; 12-month data are available for 242 patients (due to low recruitment rates, precision was recalculated for 242 evaluable patients: the precision was then of 1.0 letters). Mean age (± standard deviation) was 66.1 ± 11.0 years and 56.6% were male. The mean baseline BCVA and CSFT were 59.2 letters (95% confidence interval [CI] 57.3, 61.0) and 457 µm (95% CI: 438, 476), respectively. At month 12, the mean gain in BCVA from baseline was 7.4 letters (95% CI: 5.4, 9.4), with 36.8% of patients with BCVA > 70 letters versus 13.2% at baseline. Mean change in CSFT was -125 µm (95% CI: -146, -103). The mean number of ranibizumab injections was 5.1 ± 2.3 over an average of 10.4 ± 3.0 visits. No new safety findings were identified. CONCLUSIONS: The BOREAL study confirms the effectiveness and safety of ranibizumab for the treatment of DME-related visual impairment in routine clinical practice with fewer injections than reported in clinical trials.


Subject(s)
Angiogenesis Inhibitors/therapeutic use , Diabetic Retinopathy/drug therapy , Macular Edema/drug therapy , Ranibizumab/therapeutic use , Vision Disorders/etiology , Adult , Aged , Aged, 80 and over , Diabetic Retinopathy/physiopathology , Female , Humans , Intravitreal Injections , Macular Edema/physiopathology , Male , Middle Aged , Prospective Studies , Visual Acuity/physiology
13.
J Ophthalmol ; 2018: 8656495, 2018.
Article in English | MEDLINE | ID: mdl-30116635

ABSTRACT

PURPOSE: To assess treatment interval extension after switching from ranibizumab to aflibercept intravitreal injections in macular edema (ME) due to central retinal vein occlusion (CRVO) with an insufficient response or frequent recurrences to initial treatment. METHODS: CRVO eyes treated with ranibizumab injections on a treat-and-extend (TAE) basis with an insufficient response or frequent recurrences were switched to aflibercept. Primary endpoint was the change in injection intervals before and after the switch. RESULTS: Eleven eyes were included in this retrospective bicentric study. Before switching, patients received a mean number of 15.3 ranibizumab injections (range, 6-34) during a mean follow-up of 23.4 months (range, 6-57). After switching to aflibercept, patients received a mean number of 12.4 injections (range, 6-20) during a mean follow-up of 25.5 months (range, 16-38). Treatment interval could be extended from 6.1 (range, 4-8) to 11 weeks (range, 8-16) (p=0.001) corresponding to a mean extension of injection interval of +4.9 weeks. CONCLUSION: In case of insufficient response or frequent recurrences of ME due to CRVO in patients treated with ranibizumab on a TAE basis, switching to aflibercept could allow extending treatment intervals, which could reduce the injection burden for these patients.

14.
Retina ; 38(8): 1562-1570, 2018 08.
Article in English | MEDLINE | ID: mdl-28574924

ABSTRACT

PURPOSE: To study correlations in patients with retinal vein occlusion between the automatically quantified macular vascular densities in the superficial and deep capillary plexus (DCP) obtained using optical coherence tomography angiography (OCTA) and the data from conventional examination, particularly visual acuity and peripheral retinal nonperfusion assessed using fluorescein angiography (FA). METHODS: Retrospective, observational study of patients with retinal vein occlusion who underwent a comprehensive ophthalmic examination including FA and OCTA using the AngioVue OCTA system version 2015.100.0.35 (OptovueRTVue XR 100; AVANTI, Inc, Fremont, CA). Vascular densities in the superficial capillary plexus and DCP, as well as the area of the foveal avascular zone, were measured using the AngioAnalytics software. RESULTS: Our study of 65 eyes of 61 patients (33 men, mean age: 67 years) showed a significant correlation between peripheral nonperfusion on FA and (1) automatically quantified global vascular density in both plexus (P = 0.021 for the DCP) and (2) foveal avascular zone area (P = 0.037). We also found significant correlations between capillary dropouts in both plexus and peripheral nonperfusion (P < 0.001 for both) and between visual acuity and vascular densities (P = 0.002 for the global density in the DCP). Global density less than 46% in the DCP was associated to the presence of peripheral nonperfusion area on FA (P = 0.003) and to enlargement of the superficial foveal avascular zone (P = 0.002). CONCLUSION: Our study demonstrated a significant correlation between automatically quantified macular vascular density on OCTA and peripheral nonperfusion on FA; OCTA could help identify high-risk retinal vein occlusion patients who may benefit from further evaluation using FA.


Subject(s)
Macula Lutea/blood supply , Retinal Vein Occlusion/physiopathology , Retinal Vessels/pathology , Tomography, Optical Coherence/methods , Visual Acuity/physiology , Adult , Aged , Aged, 80 and over , Female , Fluorescein Angiography , Fovea Centralis/blood supply , Humans , Macula Lutea/diagnostic imaging , Male , Middle Aged , Retinal Vein Occlusion/pathology , Retinal Vessels/diagnostic imaging , Retrospective Studies
15.
J Adv Nurs ; 74(4): 827-837, 2018 Apr.
Article in English | MEDLINE | ID: mdl-29117448

ABSTRACT

AIMS: The objectives of the study were to: (1) examine the relationships between three different qualitative perceptions of safety culture and the Canadian Patient Safety Climate Survey factors; (2) determine whether these perceptions are associated with different hand hygiene practices. BACKGROUND: Healthcare-associated infections and safety cultures are a worldwide issue. During the A/H1N1 Influenza pandemic, Europe and North America did not have the same responses. Importantly, healthcare professionals' perceptions can influence patient safety through infection prevention practices like hand hygiene. DESIGN: A cross-sectional design was used with data collected in 2015. METHODS: The Canadian Patient Safety Culture Survey and hand hygiene observations were gathered from three healthcare centres (two Canadian and one European). Descriptive analyses and ANOVAs were conducted to explore healthcare professionals' safety perceptions and practices. RESULTS: The rates of hand hygiene practices varied widely between the three sites, ranging from 35-77%. One site (Site 3) was found to have the highest scores of management follow-up, feedback about incidents, supervisory leadership for safety, unit learning culture and senior leadership support for safety, and the highest levels of overall patient safety grades for the unit and organization. CONCLUSION: The quantitative results of this study support the previously described model based on qualitative results: individual culture, blaming culture and collaborative culture. Differences between continents emerged regarding infection prevention practices and the way we qualify infections. The results raise concerns about infection practices and about safety cultures and challenges worldwide.


Subject(s)
Cross Infection/prevention & control , Guideline Adherence , Hand Hygiene/organization & administration , Health Personnel/psychology , Patient Safety/standards , Risk Management/organization & administration , Safety Management/organization & administration , Attitude of Health Personnel , Belgium , Canada , Cross-Sectional Studies , Female , Humans , Male , Surveys and Questionnaires
16.
Health Care Manag (Frederick) ; 36(2): 129-139, 2017.
Article in English | MEDLINE | ID: mdl-28375944

ABSTRACT

Patient safety has become a worldwide concern in relation to infectious diseases (Ebola/severe acute respiratory syndrome/flu). During the pandemic, different sanitary responses were documented between Europe and North America in terms of vaccination and compliance with infection prevention and control measures. The purpose of this study was to explore the health care professionals' perceptions of biological risks, patient safety, and their practices in European and Canadian health care facilities. A qualitative-descriptive design was used to explore the perceptions of biological risks and patient safety practices among health care professionals in 3 different facilities. Interviews (n = 39) were conducted with health care professionals in Canada and Europe. The thematic analysis pinpointed 3 main themes: risk and infectious disease, patient safety, and occupational health and safety. These themes fit within safety cultures described by participants: individual culture, blame culture, and collaborative culture. The preventive terminology used in the European health care facility focuses on hospital hygiene from the perspective of environmental risk (individual culture). In Canadian health care facilities, the focus was on risk management for infection prevention either from a punitive perspective (blame culture) or from a collaborative perspective (collaborative culture). This intercultural dialogue described the contextual realities on different continents regarding the perceptions of health care professionals about risks and infections.


Subject(s)
Health Personnel , Patient Safety , Professional Practice , Attitude of Health Personnel , Canada , Humans , Risk
17.
Dev Ophthalmol ; 58: 139-167, 2017.
Article in English | MEDLINE | ID: mdl-28351046

ABSTRACT

Retinal vein occlusions (RVOs) have been defined as retinal vascular disorders characterized by dilatation of retinal veins with retinal and subretinal hemorrhages, macular edema, and a varying degree of retinal ischemia. Retinal angiography, either as fluorescein and indocyanine green (ICG) angiography or in the form of optical coherence tomography (OCT)-based angiography, is essential for the diagnosis and assessment of the prognosis of RVOs. It allows the differentiation of diverse types of RVOs, such as perfused or nonperfused, as well as the detection of different modalities in the natural history of RVOs. OCT angiographic imaging in combination with dye angiography (fluorescein or ICG) is the most effective method to assess the amount and location of cystoid macular edema and the persistence, regression, and degree of ischemia. OCT can additionally display the presence and integrity of the outer limiting membrane and of the inner and outer segments of the photoreceptors as useful biomarkers for the prognosis and as a guide for the treatment of RVO. Due to the relatively often benign and self-limiting course of nonischemic RVOs, therapy may initially be delayed. If macular edema extends into the foveolar region and persists, intravitreal medical therapy including steroids (triamcinolone; fluocinolone or dexamethasone in slow-release devices) and/or anti-VEGF (vascular endothelial growth factor) drugs (bevacizumab, ranibizumab, aflibercept) may be intravitreally administered, avoiding the irreversibly destructive effect of laser coagulation, which previously was applied in a 'grid' pattern over the extrafoveolar leaking area. The side effects of intraocularly applied steroids in relatively young patients including cataract formation and ocular hypertension have to be considered.


Subject(s)
Disease Management , Fluorescein Angiography/methods , Retinal Vein Occlusion , Tomography, Optical Coherence/methods , Visual Acuity , Fundus Oculi , Humans , Retinal Vein Occlusion/diagnosis , Retinal Vein Occlusion/epidemiology , Retinal Vein Occlusion/therapy
18.
Retina ; 37(6): 1176-1184, 2017 Jun.
Article in English | MEDLINE | ID: mdl-27685676

ABSTRACT

PURPOSE: To evaluate changes of vascular flow of patients treated with intravitreal injections of anti-vascular endothelial growth factor for macular edema secondary to retinal vein occlusion (RVO) with optical coherence tomography angiography (OCTA). METHODS: Patients with RVO with macular edema and treated with intravitreal injections of anti-vascular endothelial growth factors were retrospectively evaluated. The following examinations were performed before and after treatment: best-corrected visual acuity, spectral domain optical coherence tomography, fluorescein angiography, and OCTA (Optovue, Inc). Automatic measurement of vascular density of the superficial and deep capillary plexus was also performed and compared with age- and sex-matched healthy subjects. RESULTS: Twenty-eight eyes of 28 patients (mean age 66.2 years; males 19%) were evaluated, including 13 central RVO, 11 branch RVO, and 4 hemicentral RVO. After treatment, mean central macular thickness significantly decreased from 644 µm to 326 µm and best-corrected visual acuity increased from 20/125 to 20/63 (P < 0.01 for both results). On OCTA, perifoveal capillary disruption (P = 0.029) and the number of cysts in the superficial capillary plexus and deep capillary plexus (P < 0.002) significantly decreased after treatment. The mean vascular density in the superficial capillary plexus slightly decreased during follow-up from 46.44% to 45.01% (not significantly). These densities were significantly less than those observed in healthy controls (P < 0.001). CONCLUSION: Optical coherence tomography angiography showed regression of macular edema, reduced capillary disruption and cysts, and slight decrease in mean macular vascular density with time and despite treatment. Thus, OCTA enables qualitative and quantitative evaluation during follow-up of patients treated for RVO.


Subject(s)
Bevacizumab/administration & dosage , Fluorescein Angiography/methods , Retinal Vein Occlusion/diagnosis , Retinal Vein/pathology , Tomography, Optical Coherence/methods , Vascular Endothelial Growth Factor A/antagonists & inhibitors , Aged , Angiogenesis Inhibitors/administration & dosage , Female , Follow-Up Studies , Fundus Oculi , Humans , Male , Middle Aged , Retinal Vein/drug effects , Retinal Vein Occlusion/drug therapy , Retrospective Studies , Time Factors , Treatment Outcome , Visual Acuity
19.
Invest Ophthalmol Vis Sci ; 57(9): OCT211-23, 2016 07 01.
Article in English | MEDLINE | ID: mdl-27409475

ABSTRACT

PURPOSE: To establish a normative database for vascular density (VD) and foveal avascular zone (FAZ) at the superficial (SCP) and deep capillary plexus (DCP) in healthy subjects with optical coherence tomography (OCT) angiography. METHODS: The study was a retrospective chart review of healthy patients who had undergone OCT angiography imaging. A 3- × 3-mm area, centered on the fovea, was scanned for all the study eyes. The automated segmentation allowed separate analysis of the SCP, the DCP, and a comprehensive C-scan including both vascular layers. On the obtained images, VD and FAZ measurements were computed. Interobserver reproducibility and intraobserver repeatability were also assessed. RESULTS: A total of 135 eyes of 70 subjects (51% male) were analyzed. The mean age was 48.3 ± 17.5. We divided patients into group 1, from 20 to 39 years of age; group 2, from 40 to 59 years; and group 3, age 60 years or older. At the level of the SCP, mean VD and mean FAZ ± SD were, respectively, 52.58 ± 3.22% and 0.28 ± 0.1 mm2. At the level of the DCP, mean VD and mean FAZ were 57.87 ± 2.82% and 0.37 ± 0.12 mm2, respectively. The mean VD was significantly higher (P < 0.05) in DCP compared with SCP in all Early Treatment Diabetic Retinopathy Study (ETDRS) sectors and in all age groups. Vascular density was higher in women than in men after 60 years (P < 0.01). After adjustment on the signal strength index (SSI), the mean VD remained directly correlated with the age range and sex. The mean FAZ area was lower in group 3 (P < 0.05). Interobserver reproducibility was 0.78 to 0.99 in SCP and 0.67 to 0.92 in DCP, and intraobserver repeatability was 0.64 to 0.93 in SCP and 0.63 to 0.87 in DCP. CONCLUSIONS: Our study has provided, for the first time, age-related VD mapping data using OCT angiography in healthy subjects. The prototype software used in this study may help to improve the concept of VD grading with high inter- and intraexaminer repeatability and interexaminer reproducibility.


Subject(s)
Aging , Fluorescein Angiography/methods , Macula Lutea/diagnostic imaging , Retinal Vessels/diagnostic imaging , Tomography, Optical Coherence/methods , Adult , Aged , Capillaries/diagnostic imaging , Female , Follow-Up Studies , Fundus Oculi , Humans , Male , Middle Aged , ROC Curve , Reference Values , Reproducibility of Results , Retrospective Studies , Young Adult
20.
Eur J Ophthalmol ; 26(5): 460-8, 2016 Aug 04.
Article in English | MEDLINE | ID: mdl-27405288

ABSTRACT

PURPOSE: To quantitatively and qualitatively analyze patients with macular edema secondary to retinal vein occlusion (RVO) and treated with the intravitreal dexamethasone implant using optical coherence tomography angiography (OCTA). METHODS: The files of patients treated with intravitreal injection of dexamethasone implant for macular edema secondary to RVO were retrospectively analyzed. Before and after injection, the following data were recorded: best-corrected visual acuity (BCVA), central macular thickness (CMT) measured using spectral-domain optical coherence tomography, fluorescein angiography, and OCTA (Optovue, Inc., Fremont, CA, USA). Results of automatic measurement of vascular density of the superficial capillary plexus (SCP) and deep capillary plexus were obtained before and after treatment and compared to those of healthy subjects matched for age and sex. RESULTS: Seven eyes of 7 patients (mean age, 76 years; 57% male) were analyzed, including 3 cases of central RVO and 4 cases of branch RVO. All patients received 1 intravitreal injection of dexamethasone implant. After a mean follow-up of 2 months, CMT significantly decreased from 657 µm to 324 µm on average and BCVA increased from 20/100 to 20/50 (p = 0.017 and p<0.001, respectively). At the SCP, the mean whole en face vascular density slightly decreased during follow-up from 43.21% to 42.76% (not statistically significant). Vascular densities were largely inferior to those observed in control subjects (p≤0.01 in all quadrants). CONCLUSIONS: This study confirms the potential contribution of OCTA as a novel noninvasive imaging technology that enables a quantitative and qualitative evaluation of the follow-up of macular edema in RVO. Optical coherence tomography angiography may complement advantageously multimodal imaging to monitor patients with RVO.


Subject(s)
Dexamethasone/administration & dosage , Glucocorticoids/administration & dosage , Macular Edema/diagnostic imaging , Macular Edema/drug therapy , Retinal Vein Occlusion/diagnostic imaging , Retinal Vein Occlusion/drug therapy , Aged , Aged, 80 and over , Drug Implants , Female , Fluorescein Angiography , Follow-Up Studies , Humans , Intravitreal Injections , Macular Edema/etiology , Male , Middle Aged , Retinal Vein Occlusion/complications , Retrospective Studies , Tomography, Optical Coherence , Treatment Outcome , Visual Acuity/physiology
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