Short-Term Effects of Adding Topical Ketorolac to Intravitreal Bevacizumab in Diabetic Macular Edema: A Crossover Randomized Clinical Trial.

Purpose: To evaluate the short-term additive effects of topical ketorolac to intravitreal bevacizumab (IVB) in the management of center-involved diabetic macular edema (CI-DME). Methods: In a randomized double-masked placebo-controlled crossover clinical trial, eyes with CI-DME and the best-corrected visual acuity (BCVA) between (20/40) and (20/400) were included. These eyes should have had at least one intravitreal anti-VEGF injection in the preceding two months. They were randomized into two groups; while both groups received two IVB injections with a six-week interval, one group received topical ketorolac every 6 hr in the first interval and artificial tears every 6 hr as a placebo in the second interval and the other group received the same medications using a crossover method. The main outcome measures were changes in BCVA and central macular thickness (CMT). Results: Fifty-seven eyes of 35 patients with CI-DME were included in the study. The mean BCVA improvement was -0.09 ± 0.47 logMAR in the periods of receiving ketorolac and -0.03 ± 0.12 logMAR in the periods of placebo treatment, respectively (P = 0.99). Corresponding changes in CMT were -13.1 ± 170.1 and +11.7 ± 157.7 µm in the ketorolac and placebo periods, respectively (P = 0.322). The treatment effect was not statistically significant regarding both BCVA and CMT changes. Statistical analysis also disclosed that the carryover effect was insignificant for BCVA and CMT. Although the period effect was not significant for BCVA, it was at a meaningful level for CMT changes (P = 0.012). Conclusion: This crossover clinical trial demonstrated that in the course of DME treatment with IVB injections, topical ketorolac did not have any additive beneficial effect at least during a six-week period.

Superficial Retinal Microvasculature and Choriocapillaris Alterations after Photodynamic Therapy in Chronic Central Serous Chorioretinopathy.

Purpose: To compare superficial retinal vascular, choriocapillaris (CC), and choroidal thickness changes in chronic central serous chorioretinopathy (CSCR) patients after half-dose photodynamic therapy (PDT). Method: In this prospective interventional case series study, fifteen eyes of 14 patients with chronic CSCR undergoing half-dose PDT treatment were enrolled. All patients underwent enhanced depth imaging optical coherence tomography angiography (EDI-OCT) and optical coherence tomography angiography (OCTA) at baseline and 3 months after treatment. Best-corrected visual acuity (BCVA), superficial retinal vascular density, CC vessel density, foveal avascular zone (FAZ), central macular thickness (CMT), and choroidal thickness were compared. Results: Mean BCVA before and after PDT was 0.34 ± 0.26 and 0.19 ± 0.25 logMAR, respectively (p=0.011). Mean FAZ before treatment was 410.21 ± 117.00 µm2, which increased to 433.50 ± 116.76 µm2 (P=0.253). Mean vessel density at superficial capillary plexus (SCP) was 38.93 ± 11.12 at baseline, which increased to 39.04 ± 11.43 (P=0.886). Mean CC vessel density was 53.21 ± 4.14 at baseline, which significantly decreased to 51.85 ± 4.21 (P=<0.001). BCVA has no significant correlation with FAZ (P=0.282) and vessel density (P=0.0.241) at SCP. CMT significantly decreased from 380.87 ± 41.66 µ at baseline to 268.20 ± 28.07 µ at 3 months (P=0.132). We did not find any correlation between CMT and FAZ (P=0.040) and vessel density (P=0.686) at SCP. Mean subfoveal choroidal thickness reduced from 411 ± 171 µm before treatment to 372 ± 117 µm (P=0.106). Conclusion: PDT treatment can affect retinal and choroidal structural parameters, but we could not find any significant influence on retinal vascular parameters, including FAZ area and vessel densityonly mean CC vessel density and subfoveal choroidal thickness decreased.

Mini vitrectomy as an alternative technique for intraocular pressure adjustment in non-drainage scleral buckling.

Purpose: In non-drainage scleral buckling, anterior chamber paracentesis is usually carried out to decrease intraocular pressure. When the buckling is extensive however, this technique may be inefficient and time consuming. In this study, we tried to determine if a mini 25-gauge pars plana vitrectomy could be used as an efficient and safe alternative procedure to anterior chamber paracentesis for adjusting intraocular pressure during a non-drainage scleral buckling. Methods: In this case series, 44 patients with rhegmatogenous retinal detachment (proliferative vitreoretinopathy stage < C) were included. In all cases, a mini 25-gauge pars plana vitrectomy was performed before buckle fixation and repeated if necessary. Complete retinal attachment was defined as the anatomical success. Results: Forty-four eyes of 44 patients with mean age of 48.1 ± 18.2 years were included. Silicon buckle nº 276, sponge 505, and sponge 507 were utilized for 7, 34, and 3 eyes, respectively. Intravitreal injection of SF6 gas was performed for 54.5% of the eyes. Mean total time of the operation was 61 ± 16 min and the mean time for vitrectomy was 87 ± 31 s. Complete retinal attachment in 37 and incomplete attachment in 4 eyes were achieved after single operation that was a success rate of 93.2%. One had more than usual vitreous leak at the site of scleretomy and one developed a tiny vitreous hemorrhage at the sclerotomy site. Three sclerotomy sites needed suturing. Conclusion: The anatomical outcome and the safety observed in this study were comparable to the current methods reported in the literature. Therefore, if anterior chamber paracentesis fails to adjust intraocular pressure during a non-drainage scleral buckling, performing a small gauge mini vitrectomy is safe and helpful.

Mini vitrectomy as an alternative technique for intraocular pressure adjustment in non-drainage scleral buckling / La minivitrectomía como técnica alternativa para el ajuste de la presión intraocular en el cerclaje escleral sin drenaje

Purpose In non-drainage scleral buckling, anterior chamber paracentesis is usually carried out to decrease intraocular pressure. When the buckling is extensive however, this technique may be inefficient and time consuming. In this study, we tried to determine if a mini 25-gauge pars plana vitrectomy could be used as an efficient and safe alternative procedure to anterior chamber paracentesis for adjusting intraocular pressure during a non-drainage scleral buckling. Methods In this case series, 44 patients with rhegmatogenous retinal detachment (proliferative vitreoretinopathy stage < C) were included. In all cases, a mini 25-gauge pars plana vitrectomy was performed before buckle fixation and repeated if necessary. Complete retinal attachment was defined as the anatomical success. Results Forty-four eyes of 44 patients with mean age of 48.1 ± 18.2 years were included. Silicon buckle nº 276, sponge 505, and sponge 507 were utilized for 7, 34, and 3 eyes, respectively. Intravitreal injection of SF6 gas was performed for 54.5% of the eyes. Mean total time of the operation was 61 ± 16 min and the mean time for vitrectomy was 87 ± 31 s. Complete retinal attachment in 37 and incomplete attachment in 4 eyes were achieved after single operation that was a success rate of 93.2%. One had more than usual vitreous leak at the site of scleretomy and one developed a tiny vitreous hemorrhage at the sclerotomy site. Three sclerotomy sites needed suturing. Conclusion The anatomical outcome and the safety observed in this study were comparable to the current methods reported in the literature. Therefore, if anterior chamber paracentesis fails to adjust intraocular pressure during a non-drainage scleral buckling, performing a small gauge mini vitrectomy is safe and helpful.

PANRETINAL PHOTOCOAGULATION VERSUS INTRAVITREAL BEVACIZUMAB VERSUS A PROPOSED MODIFIED COMBINATION THERAPY FOR TREATMENT OF PROLIFERATIVE DIABETIC RETINOPATHY: A Randomized Three-Arm Clinical Trial (CTPDR Study).

PURPOSE: To compare safety and therapeutic effect of three treatment protocols on patients with naive proliferative diabetic retinopathy. METHODS: A total of 207 eyes with proliferative diabetic retinopathy were randomly divided into three groups: full panretinal photocoagulation group; intravitreal bevacizumab (IVB) group with four monthly IVB injections; and modified combination group with two bimonthly IVB injections and a modified laser therapy. The best-corrected visual acuity and area of neovascularization leakage were compared at 1-year follow-up. RESULTS: The difference in final best-corrected visual acuity was not significant between the groups (P = 0.77). The modified combination group had the lowest final leakage area (P = 0.006). The difference in final mean deviation of visual field was not significant between IVB and modified combination groups (mean difference = 0.25, P = 0.23, 95% confidence interval, 0.12-1.38). There was no difference in rate of new-onset diabetic macular edema between IVB and modified combination groups (mean difference = 1.5%, P = 0.31, 95% confidence interval, 1.1-1.88). Mean of total IVB injections were 3.5, 7.4, and 6.2 for panretinal photocoagulation, IVB, and modified combination groups, respectively (P = 0.002). Patients in the IVB group underwent more visits (P = 0.001). In subgroup analysis, the difference in the final leakage area was significant for the eyes with diabetic macular edema (P = 0.005). CONCLUSION: A combination protocol of photocoagulation and IVB can be recommended for proliferative diabetic retinopathy, especially with baseline diabetic macular edema.

SPECTRAL DOMAIN OPTICAL COHERENCE TOMOGRAPHY BIOMARKERS OF RETINAL HYPERPERMEABILITY AND CHOROIDAL INFLAMMATION AS PREDICTORS OF SHORT-TERM FUNCTIONAL AND ANATOMICAL OUTCOMES IN EYES WITH DIABETIC MACULAR EDEMA TREATED WITH INTRAVITREAL BEVACIZUMAB.

PURPOSE: To assess spectral domain optical coherence tomography biomarkers of short-term outcomes in eyes with diabetic macular edema treated with intravitreal bevacizumab. METHODS: In a prospective interventional case series, 66 eyes with diabetic macular edema underwent 3 monthly intravitreal bevacizumab injections. Best-corrected visual acuity measurement and spectral domain optical coherence tomography were performed at baseline and at 3 months. Multivariate regression analysis was performed to investigate the baseline spectral domain optical coherence tomography parameters as predictors of functional and anatomical outcomes. RESULTS: Patients with diabetic nephropathy had greater subfoveal choroidal thickness (300.8 ± 35.54 vs. 253.0 ± 50.07 µm, P < 0.01) and were more likely to have subretinal fluid (r = 0.26, P = 0.03) at baseline. Multivariate analysis showed that the extent of external limiting membrane disruption (P = 0.03) and the extent of disorganization of retinal inner layers (P = 0.03) at baseline were predictors of best-corrected visual acuity at 3 months, whereas the extent of disorganization of retinal inner layers (P = 0.04) and duration of diabetes mellitus (P = 0.03) were predictors of central subfield thickness at 3 months. CONCLUSION: External limiting membrane disruption and disorganization of retinal inner layers, as the spectral domain optical coherence tomography biomarkers of retinal hyperpermeability, can predict short-term outcomes in diabetic macular edema eyes treated with intravitreal bevacizumab.

Topical ketorolac as an adjunctive treatment with intravitreal bevacizumab in the management of diabetic macular edema: A double-masked placebo-controlled randomized clinical trial.

PURPOSE: To evaluate the additional effect of ketorolac eye drops on therapeutic effects of intravitreal Bevacizumab in patients with diabetic macular edema (DME) METHODS: In a randomized clinical trial, 50 patients with center involved DME (macular thickness ≥ 300 microns accompanied by decreased VA (24 < BCVA ≤ 70 ETDRS letters) were enrolled consecutively and randomized 1:1 to receive either bevacizumab plus topical ketorolac (25 patients) or bevacizumab plus artificial tears (25 patients). Patients with proliferative diabetic retinopathy, history of intraocular surgery, intravitreal injection in less than three months, macular photocoagulation less than 6 months and any other concomitant ocular pathologies were excluded from the study. All the patients received three consecutive monthly injections of intravitreal bevacizumab (IVB). After that, patients were examined every 6 weeks and reinjection was administered based on the "as needed" protocol if macular thickness was 300 microns or more and VA was 70 ETDRS letters or less.. Patients also received either topical ketorolac or artificial tears three times a day over the study period (6 months). Changes in central subfield thickness (CST), best-corrected visual acuity (BCVA, ETDRS letters), and number of IVB injections were compared between the study groups. RESULTS: Fifty eyes of 50 patients were included (25 eyes in each group). Mean CST was significantly decreased in both study groups at 14th week (-87 ± 98 µm, P = 0.012 and -100 ± 147 µm, P = 0.006 in bevacizumab plus ketorolac and bevacizumab plus artificial tears groups, respectively). Nevertheless, the changes of mean CST remained significant only in bevacizumab plus ketorolac group up to 26th week (-147 ± 124 µm, P < 0.001 and -51 ± 145 µm, P = 0.245, respectively). Comparing two groups, reduction of mean CST from baseline was significantly greater in bevacizumab plus ketorolac group compared with the control group at 26th week. (difference = -97 µm, 95%CI = -182 to -11, P = 0.017). In the study group, mean BCVA significantly increased at both 20th week (6.2 ± 10.1, P = 0.04) and 26th week (8.2 ± 10.9, P = 0.03). In contrast, visual acuity did not significantly improve at any time points in bevacizumab plus artificial tears group, While insignificant, the 26-week mean change of visual acuity from baseline was greater in bevacizumab plus ketorolac group (difference = 6.5 ETDRS letter; 95%CI = -14.4 to 1.4) Two groups were comparable regarding number of IVB injections (P = 0.99). CONCLUSION: Topical ketorolac 0.5% three times a day could enhance and sustain the efficacy of intravitreal bevacizumab in the treatment of DME.

Choroidal Thickness in Different Types of Inherited Retinal Dystrophies.

PURPOSE: To compare the choroidal thickness among eyes with retinitis pigmentosa (RP), Stargardt disease, Usher syndrome, cone-rod dystrophy, and healthy eyes of sex- and age-matched individuals. METHODS: In this comparative study, 503 eyes with RP (n = 264), cone-rod dystrophy (n = 109), Stargardt disease (n = 76), and Usher syndrome (n = 54) were included. To validate the data, 109 healthy eyes of 56 sex- and age-matched individuals were studied as controls. Choroidal imaging was performed using enhanced depth imaging-optical coherence tomography. Choroidal thickness was measured manually using MATLAB software at 13 points in nasal and temporal directions from the foveal center with the interval of 500 µm and the choroidal area encompassing the measured points was calculated automatically. RESULTS: The mean age was 36.33 ± 13.07 years (range, 5 to 72 years). The mean choroidal thickness at 13 points of the control eyes was statistically significantly higher than that in eyes with RP (P < 0.001) and Usher syndrome (P < 0.05), but not significantly different from that in eyes with Stargardt disease and cone-rod dystrophy. Among different inherited retinal dystrophies (IRDs), the choroidal thickness was the lowest in eyes with RP (P < 0.001). Choroidal thickness in the subfoveal area correlated negatively with best-corrected visual acuity (r = - 0.264, P < 0.001) and the duration of ocular symptoms (r = - 0.341, P < 0.001) in all studied IRDs. No significant correlation was observed between the subfoveal choroidal thickness and central macular thickness (r = - 0.24, P = 0.576). CONCLUSION: Choroidal thinning in four different types of IRDs does not follow a similar pattern and depends on the type of IRD and the duration of ocular symptoms. A larger cohort is required to verify these findings.

Combination of intravitreal bevacizumab and erythropoietin versus intravitreal bevacizumab alone for refractory diabetic macular edema: a randomized double-blind clinical trial.

PURPOSE: To evaluate the effect of three intravitreal bevacizumab (IVB) injections alone or in combination with intravitreal erythropoietin (EPO) in the treatment of refractory diabetic macular edema (DME). METHODS: In a randomized double-blind clinical trial, 48 eyes of 34 diabetic patients with refractory DME were enrolled. Eyes were randomly assigned to receive either 3 monthly injections of 0.05 cc (1.25 mg) IVB plus 0.05 cc (1000 unit) EPO or 0.05 cc (1.25 mg) IVB alone. Main outcome was best-corrected visual acuity (BCVA) changes and secondary outcome was central macular thickness (CMT). The patients were followed for 6 months. RESULTS: Mean BCVA changes up to 4 and 6 months were insignificant in both groups. It changed from 0.72 ± 0.56 logMAR at baseline to 0.74 ± 0.5 (P = 0.85) and 0.71 ± 0.44 (P = 0.40) in the combination group and from 0.48 ± 0.39 logMAR to 0.47 ± 0.35 (P = 0.48) and 0.52 ± 0.33 (P = 0.69) in the IVB alone group, at 4 and 6 months, respectively. The difference of mean BCVA changes between the groups was insignificant at both 4 and 6 months (P = 0.07 and P = 0.36, respectively). Within the group changes of mean CMT were significant only in the combination group at 4 and 6 months, from 518 ± 134 µ at baseline to 472 ± 151 to 475 ± 167 µ, respectively (P = 0.01 and P = 0.05). Corresponding changes were not significant in the IVB alone group. However, the difference between the groups was not significant at all visits (P = 0.51 and P = 0.71, respectively). CONCLUSIONS: This clinical trial demonstrated that intravitreal erythropoietin had no additional effect to IVB in the treatment of refractory DME in the short term. TRIAL REGISTRATION: Clinical trials.gov identifier: NCT03821168.

Incidence and risk factors of retinopathy of prematurity and utility of the national screening criteria in a tertiary center in Iran.

AIM: To determine the incidence and risk factors of retinopathy of prematurity (ROP) and the sensitivity of current screening criteria in a tertiary eye center in Tehran, Iran. METHODS: In a cross-sectional observational study, neonates weighing ≤2000 grams at birth or born <34wk gestational age (GA) and all other infants at risk of ROP admitted to the neonatal intensive care unit (NICU) or referred to our ROP clinic were investigated. The incidence of ROP and severe ROP (i.e. patients needing treatment) were determined. The associations between risk factors and the development and severity of ROP were assessed. We also examined the sensitivity of the current national screening guideline in Iran. RESULTS: Among 207 infants, the incidence of ROP and severe ROP was 33.3% and 11.1%, respectively. Mean GA and birth weight (BW) were significantly lower in ROP vs non-ROP infants (29±2wk vs 33±3wk, P<0.001; 1274±489 g vs 1916±550 g, P<0.001, respectively). Univariate analysis displayed significant association between ROP incidence and GA, BW, NICU admission period, blood transfusion, surfactant usage, sepsis, intraventricular hemorrhage and patent ductus arteriosus (P<0.05 for all). BW [relative risk (RR): 0.857 (0.711-0.873), P<0.001], GA [RR: 0.788 (0.711-0.873), P<0.001] and blood transfusion [RR: 1.888 (0.995-3.583), P=0.052] were independent ROP risk factors. The sensitivity of country-specific screening guidelines was 95.7% and 100% for overall and severe ROP detection, respectively. CONCLUSION: ROP incidence is relatively high in Iran. Identifying ROP risk factors results in more accurate screening and reduces the risk of irreversible vision loss. The ROP screening criteria utilized in Iran are efficient at the present time.

Visual and Anatomical Outcomes of Pars Plana Vitrectomy for Dropped Nucleus after Phacoemulsification.

PURPOSE: To determine the prognostic factors and visual and anatomic outcomes of pars plana vitrectomy (PPV) in patients with dropped nucleus following complicated phacoemulsification (PE). METHODS: The records of patients with complicated PE who underwent PPV to remove posteriorly dislocated nucleus fragments from January 2011 to December 2014 were retrospectively reviewed. RESULTS: Of 43 patients, 36 patients (36 eyes) were included with mean age of 73 ± 9.5 years and mean follow-up duration of 23.8 ± 15.3 (range 4-53) months. The mean interval between cataract surgery and PPV was 11.5 ± 9.6 (range 1-45) days. The pre-PPV mean best-corrected visual acuity (VA) was 1.04 ± 0.24 logMAR, which improved to 0.46 ± 0.18 logMAR (P < 0.001). Pre-PPV VA ≥20/200 was significantly associated with good final VA ≥20/40 (P = 0.002). Implantation of intraocular lens (IOL) at the time of complicated PE and complicated course after PPV were significantly associated with poor visual outcome of <20/40 (P = 0.041 and P < 0.001, respectively). However, the timing of PPV, route of nucleus removal, and final IOL status were not significantly associated with the visual outcome. The most frequent causes of poor visual outcome were optic atrophy, cystoid and/or diabetic macular edema, history of rhegmatogenous retinal detachment, and pre-existing eye disease (age-related macular degeneration). CONCLUSION: PPV for dropped nucleus was associated with improved VA. Better pre-PPV VA was associated with good visual outcome, while inserting IOL at the time of complicated PE, and complicated course after PPV were associated with poor visual outcome.

Intravitreal Injection of Anti-vascular Endothelial Growth Factor Agents for Ocular Vascular Diseases: Clinical Practice Guideline.

PURPOSE: To provide the clinical recommendations for the administration of intravitreal anti-vascular endothelial growth factor (VEGF) drugs especially bavacizumab for ocular vascular diseases including diabetic macular edema, neovascular age-related macular degeneration, myopic choroidal neovascularization, retinal vein occlusion and central serous chorioretinopathy. METHODS: Twenty clinical questions were developed by the guideline technical committee. Relevant websites and databases were searched to find out the pertinent clinical practice guidelines to answer the questions. The technical committee provided possible answers (scenarios) according to the available evidences for each question. All scenarios along with their levels of evidence and the supported articles were sent to the experts for external review. If the experts did not agree on any of the scenarios for one particular clinical question, the technical committee reviewed all scenarios and their pertinent evidences and made the necessary decision. After that, the experts were asked to score them again. All confirmed scenarios were gathered as the final recommendations. RESULTS: All the experts agreed on at least one of the scenarios. The technical committee extracted the agreed scenario for each clinical question as the final recommendation. Finally, 56 recommendations were developed for the procedure of intravitreal anti-VEGF injection and their applications in the management of ocular vascular diseases. CONCLUSION: The implementation of this guideline can standardize the management of the common ocular vascular diseases by intravitreal injection of anti-VEGF agents. It can lead to better policy-making and evidence-based clinical decision by ophthalmologists and optimal evidence based eye care for patients.

Effects of Intravitreal Silicone Oil on Subfoveal Choroidal Thickness.

PURPOSE: To evaluate the effects of intravitreal silicone oil (SO) on subfoveal choroidal thickness (SFCT). METHODS: A total of 60 patients with unilateral pseudophakic macula-off rhegmatogenous retinal detachment were treated with a three-port pars plana vitrectomy and a 5,700-cSt SO endo-tamponade and subsequent SO removal. SFCT was measured before and 3 months after SO removal. The main outcome measure was the difference between the SFCT of operated eyes and the fellow eyes. RESULTS: Before SO removal, the mean SFCT differences in group 1 (3-6 months' duration of SO), group 2 (6-9 months' duration of SO), and group 3 (9-18 months' duration of SO) were -14.8, -25.5, and -62.1 µm, respectively (p = 0.002, r = 0.398). Three months after SO removal, the mean SFCT differences in group 1, group 2, and group 3 were -13.4, -23.3, and -59.0 µm, respectively (p = 0.002, r = 0.393). CONCLUSION: SFCT decreased significantly in eyes with long-term (≥6 months) intravitreal SO tamponade. Choroidal thinning did not improve after SO removal.

Choroidal Thickness in Healthy Subjects.

PURPOSE: To measure the choroidal thickness by enhanced depth imaging optical coherence tomography (EDI-OCT) in normal eyes. METHODS: In a prospective case series, 208 eyes of 104 normal Iranian subjects were enrolled. Complete ophthalmic examination was performed. Inclusion criteria were best corrected visual acuity (BCVA) ≥20/20, ≤ ±1 diopter of refractive error in either spherical or cylindrical components, normal intraocular pressure (IOP) and no systemic or ocular diseases. The choroidal thickness was measured by EDI-OCT subfoveally, and 1500 µm and 3000 µm nasal and temporal to the fovea. RESULTS: Mean age was 34.6 ± 9.8 years (range, 18-57 years). Mean subfoveal choroidal thickness was 363 ± 84 µm. Choroidal thickness was 292 ± 76 and 194 ± 58 µm at 1500 and 3000 µm nasal to the fovea, respectively, and 314 ± 77 and 268 ± 66 µm at 1500 and 3000 µm temporal to the fovea, respectively. There was no statistically significant difference in the choroidal thickness between sexes and laterality of the eyes. Choroidal thickness at fovea (P < 0.001) and at all extrafoveal locations decreased significantly for every 10 years increase in age. CONCLUSION: In normal Iranian subjects participating in this study, mean choroidal thickness was comparable with other reports.

Peripapillary retinal nerve fiber layer thickness in preeclampsia and eclampsia.

PURPOSE: To evaluate peripapillary retinal nerve fiber layer (RNFL) thickness during and after pregnancy in pregnant women with preeclampsia or eclampsia and compare it with normotensive pregnant women as controls. METHODS: In a prospective comparative case-control study 35 women (70 eyes) with mild to moderate preeclampsia, 70 women (140 eyes) with severe preeclampsia and eclampsia, and 44 (88 eyes) healthy pregnant women were enrolled in three groups. Peripapillary RNFL thickness in three groups was measured after 28 weeks of pregnancy and 2 months postpartum by using optical coherence tomography. Mean and quadratic RNFL thickness changes were compared within and among the groups. RESULTS: Mean peripapillary RNFL thickness decreased significantly from 104 ± 10, 104 ± 23, and 106 ± 9 µm during pregnancy to 101 ± 10, 96 ± 10, and 103 ± 9 µm 2 months after pregnancy in the mild to moderate preeclampsia, severe preeclampsia and eclampsia, and healthy pregnant women groups, respectively (P < 0.001 for all). While the difference among the groups was insignificant during pregnancy, it reached to a significant level after delivery (P = 0.006). The highest reduction in mean RNFL thickness (6 ± 10 µm) occurred in the severe preeclampsia and eclampsia groups. CONCLUSIONS: In relation to the time of pregnancy, peripapillary RNFL reduced in preeclamptic and eclamptic cases as well as in normotensive pregnant women at 2 months postpartum. This reduction was more in the severe forms of pregnancy-induced hypertension.

Traumatic optic neuropathy treatment trial (TONTT): open label, phase 3, multicenter, semi-experimental trial.

PURPOSE: Intravenously administered erythropoietin (EPO) was firstly commenced (phase 1) in patients with indirect traumatic optic neuropathy (TON) by this group in 2011. It was re-tested by another group (phase 2) in 2014. This multicenter clinical trial was designed to compare its effect with intravenous steroid and observation. METHODS: Included were TON patients ≥5 years of age and with trauma-treatment interval of ≤3 weeks. Follow-up visits were set at 1, 2, 3, 7, 14, 30, and at least 90 days after treatment. EPO and methylprednisolone were infused intravenously every day for three consecutive days. Primary outcome measure was change in the best corrected visual acuity (BCVA). Secondary outcomes included change in color vision and relative afferent pupillary defect (RAPD), side effects, and factors affecting the final visual improvement. RESULTS: Out of 120 patients, 100 (EPO: 69, steroid: 15, observation: 16) were finally included. All three groups showed a significant improvement of BCVA which was not significantly different between the groups (adjusted for pretreatment BCVA). Color vision was significantly improved in the EPO group. Late treatment (>3 days) (odds ratio = 2.53) and initial BCVA of NLP (odds ratio = 5.74) significantly worsened visual recovery. No side effect was observed in any group. CONCLUSION: EPO, steroid, and observation showed a significant improvement of BCVA in patients with TON. Initial BCVA of NLP and late treatment (>3 days) were significant risk factors for visual improvement.

Predictors and Outcomes of Vitrectomy and Silicone Oil Injection in Advanced Diabetic Retinopathy.

PURPOSE: To evaluate visual and anatomical results and identify factors that influence vitrectomy and silicone oil (SO) injection outcomes in proliferative diabetic retinopathy (PDR). METHODS: This retrospective study included 236 eyes with PDR that were undergoing vitrectomy and SO injection with >3-month follow-up. The primary outcomes were final best-corrected visual acuity (BCVA) and retinal attachment rate. RESULTS: At the final visit (mean, 88 ± 58 weeks), complete, partial, and no retinal attachment were observed in 86.9%, 10.6%, and 2.5% of patients, respectively. A total of 155 eyes had experienced SO removal, while 81 had SO in place. The mean initial BCVA was 1.9 ± 0.7 logarithm of the minimum angle of resolution (logMAR) and significantly improved to 1.7 ± 0.8 logMAR (p = 0.001). Initial macular detachment (adjusted odds ratio [AOR], 0.25), development of iatrogenic break (AOR, 0.25), and use of heavy SO (AOR, 0.13) were independently associated with a lower risk of final retinal attachment, and SO removal was associated with a higher incidence (AOR, 7.55). Better baseline BCVA was associated with a higher risk of final BCVA ≥20 / 200. CONCLUSIONS: Despite an encouraging outcome based on anatomical data in advanced PDR treated with vitrectomy and SO, the functional prognosis was not satisfying for patients. Eyes with better vision at baseline had a more favorable prognosis, whereas eyes with initial macular detachment, intraoperative iatrogenic break, or heavy SO showed more unfavorable outcomes. In selected cases, extending the time of SO use did not worsen the prognosis.

Analgesic Effect of Topical Sodium Diclofenac before Retinal Photocoagulation for Diabetic Retinopathy: A Randomized Double-masked Placebo-controlled Intraindividual Crossover Clinical Trial.

PURPOSE: To evaluate the analgesic effect of topical sodium diclofenac 0.1% before retinal laser photocoagulation for diabetic retinopathy. METHODS: Diabetic patients who were candidates for peripheral laser photocoagulation were included in a randomized, placebo-controlled, intraindividual, two-period, and crossover clinical trial. At the first session and based on randomization, one eye received topical sodium diclofenac 0.1% and the other eye received an artificial tear drop (as placebo) three times before laser treatment. At the second session, eyes were given the alternate drug. Patients scored their pain using visual analogue scale (max, 10 cm) at both sessions. Patients and the surgeon were blinded to the drops given. Difference of pain level was the main outcome measure. RESULTS: A total of 200 eyes of 100 patients were enrolled. Both treatments were matched regarding the applied laser. Pain sensation based on visual analogue scale was 5.6 ± 3.0 in the treated group and 5.5 ± 3.0 in the control group. The calculated treatment effect was 0.15 (95% confidence interval, -0.27 to 0.58; p = 0.486). The estimated period effect was 0.24 (p = 0.530) and the carryover effect was not significant (p = 0.283). CONCLUSIONS: Pretreatment with topical sodium diclofenac 0.1% does not have any analgesic effect during peripheral retinal laser photocoagulation in diabetic patients.

The effect of topical sodium diclofenac on macular thickness in diabetic eyes after phacoemulsification: a randomized controlled trial.

To evaluate the efficacy of prophylactic administration of the topical diclofenac 0.1 % on macular thickness in diabetic patients following phacoemulsification and intraocular lens implantation surgery. In a Randomized double-masked clinical trial, 108 eyes of 108 diabetic patients underwent phacoemulsification and intraocular lens implantation surgery were enrolled. Fifty four eyes received the conventional postoperative care with steroid drop, whereas the other group (54 eyes) was given a preoperative diclofenac drop four times daily in addition to steroid drop and continued 6 weeks after surgery. All patients were evaluated by optical coherence tomography (OCT) preoperatively and days 1, 30, and 90. The outcome measures including best-corrected visual acuity and OCT findings were compared in and between both groups. Mean CMT changed from 239 ± 16 and 235 ± 17 at baseline to 249 ± 15 and 254 ± 28 at 3 months in the case and control groups, respectively(p = 0.003). Mean total volume of macula changed from 7.61 ± 0.22 and 7.56 ± 0.3 at baseline to 7.64 ± 0.22 and 7.65 ± 0.31 at 3 months in the case and control groups, respectively (p = 0.820). In comparison to the quadrants thicknesses and mean of them between groups did not reach the significant level. This study showed that there is a beneficial effect of topical diclofenac for prevention of macular thickness increasing following phacoemulsification in diabetic patients.

Diabetic Retinopathy Clinical Practice Guidelines: Customized for Iranian Population.

PURPOSE: To customize clinical practice guidelines (CPGs) for management of diabetic retinopathy (DR) in the Iranian population. METHODS: Three DR CPGs (The Royal College of Ophthalmologists 2013, American Academy of Ophthalmology [Preferred Practice Pattern 2012], and Australian Diabetes Society 2008) were selected from the literature using the AGREE tool. Clinical questions were designed and summarized into four tables by the customization team. The components of the clinical questions along with pertinent recommendations extracted from the above-mentioned CPGs; details of the supporting articles and their levels of evidence; clinical recommendations considering clinical benefits, cost and side effects; and revised recommendations based on customization capability (applicability, acceptability, external validity) were recorded in 4 tables, respectively. Customized recommendations were sent to the faculty members of all universities across the country to score the recommendations from 1 to 9. RESULTS: Agreed recommendations were accepted as the final recommendations while the non-agreed ones were approved after revision. Eventually, 29 customized recommendations under three major categories consisting of screening, diagnosis and treatment of DR were developed along with their sources and levels of evidence. CONCLUSION: This customized CPGs for management of DR can be used to standardize the referral pathway, diagnosis and treatment of patients with diabetic retinopathy.