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1.
Clin Ophthalmol ; 18: 1391-1401, 2024.
Article in English | MEDLINE | ID: mdl-38784434

ABSTRACT

Purpose: To evaluate both the early experience of real-world patients treated with dexamethasone ophthalmic insert (0.4 mg; DEXTENZA®), hereafter referred to as DEX, after cataract surgery as well as staff/practice integration of DEX relative to eyedrops. Patients and Methods: This was a cross-sectional survey study of 23 cataract practices in the United States. Respondents were patients and practice staff who had experience with DEX following cataract surgery. Both patients and practice staff completed an online survey. Descriptive statistics summarized the survey responses to portray the experience of the respondents. Results: Surveys were completed by 62 patients and 19 practice staff. Almost all patients (93%) were satisfied or extremely satisfied with DEX. Patients highly preferred DEX (93%) to topical steroid drops (7%) based on past experiences with topical steroid drops. Most practice staff (95%) were satisfied or highly satisfied with DEX, reporting a 45% reduction in time spent educating patients on postoperative drop use and a 46% decrease in time spent addressing calls from pharmacies regarding postoperative medications. Conclusion: Incorporating the DEX insert into clinical practice in cataract surgery practices can improve patient adherence, while potentially providing significant savings to practices in terms of time spent educating patients and responding to patient and pharmacy call-backs.

2.
J Cataract Refract Surg ; 49(4): 443, 2023 04 01.
Article in English | MEDLINE | ID: mdl-36975015

ABSTRACT

A 24-year-old woman presented with a 7-day history of blurry vision, redness, and extreme pain in her right eye. She had no pertinent medical or ocular history and did not use spectacles or contacts. Uncorrected distance visual acuity (UDVA) was 20/40 in the right eye and could not be improved with refraction. Slitlamp examination revealed a 1.5 × 1.5 mm central epithelial defect with surrounding white blood cell recruitment. Confocal microscopy (Figure 1JOURNAL/jcrs/04.03/02158034-202304000-00020/figure1/v/2023-03-24T200747Z/r/image-tiff) was performed, and she was treated with chlorhexidine 0.02% drops every hour in the right eye. 2 weeks later, the cornea had completely re-epithelialized; however, persistent corneal haze, decreased visual acuity, and corneal thinning and flattening was noted. Pachymetry was 484 µm in the right eye and UDVA was 20/40 (Supplemental Figure 1, available at http://links.lww.com/JRS/A836). In the following 2 weeks, UDVA improved to 20/25. 6 months after the initial presentation, UDVA was unchanged and faint central corneal haze was noted on examination (Figure 2JOURNAL/jcrs/04.03/02158034-202304000-00020/figure2/v/2023-03-24T200747Z/r/image-tiff). Of interest, her family history is significant for her younger 16-year-old brother with 3 prior episodes of a similar type of keratitis/keratopathy over the course of 2 years in both eyes with similar central paracentral corneal haze, thinning, and flattening and similar confocal findings (Figure 3JOURNAL/jcrs/04.03/02158034-202304000-00020/figure3/v/2023-03-24T200747Z/r/image-tiff). He also was unresponsive to topical antibiotics and antivirals except topical chlorhexidine. Her brother has been our patient for the last several years prior to her first visit to our clinic. What is your diagnosis? What medical diagnostic tests, if any, would you recommend? Is this an infectious or simply an inflammatory response? Is there any genetic or familial predisposition?


Subject(s)
Chlorhexidine , Corneal Opacity , Keratitis , Adult , Female , Humans , Chlorhexidine/administration & dosage , Chlorhexidine/therapeutic use , Cornea/pathology , Corneal Opacity/diagnosis , Corneal Opacity/drug therapy , Keratitis/diagnosis , Keratitis/drug therapy , Refraction, Ocular
3.
Cornea ; 42(1): 89-96, 2023 Jan 01.
Article in English | MEDLINE | ID: mdl-36256386

ABSTRACT

PURPOSE: The purpose of this study was to assess the impact of ongoing waves of the COVID-19 pandemic and resulting guidelines on the corneal donor pool with resumption of clinical operations. METHODS: A retrospective analysis of donors deemed eligible for corneal transplantation at an eye bank from July 1, 2020, through December 31, 2021. Donors ineligible due to meeting Eye Bank Association of America (EBAA) COVID-19 guidelines or a positive postmortem COVID-19 testing were examined. The correlation between COVID-19 rule outs and state COVID positivity was calculated. The number of scheduled surgeries, suitable corneas, imports, and international exports was compared with a pre-COVID period. Postmortem testing was reduced for the final 5 months of the study, and numbers were compared before and after the policy change. RESULTS: 2.85% of referrals to the eye bank were ruled out because of EBAA guidelines. 3.2% of postmortem tests were positive or indeterminate resulting in an ineligible tissue donor (0.42% of referrals). Over the 18-month period, there was a 4.30% shortage of suitable corneas compared with transplantation procedures. There was a significant correlation between postmortem testing and state COVID-19 positivity (r = 0.37, P <0.01), but not with EBAA guidelines (r = 0.19, P = 0.07). When postmortem testing was reduced, significantly more corneas were exported internationally. CONCLUSIONS: Although corneal transplant procedures were back to normal levels, there was a shortage of suitable corneal tissue. The discontinuation of postmortem testing was associated with a significant increase in international exports of corneal donor tissue.


Subject(s)
COVID-19 , Corneal Transplantation , Humans , Eye Banks/methods , Pandemics , COVID-19/epidemiology , Retrospective Studies , COVID-19 Testing , Corneal Transplantation/methods , Tissue Donors , Cornea
4.
Clin Ophthalmol ; 16: 2429-2440, 2022.
Article in English | MEDLINE | ID: mdl-35968052

ABSTRACT

Purpose: To describe the early real-world experience of physicians with an intracanalicular dexamethasone insert (DEX) in patients undergoing cataract surgery and to capture the clinical impact of adopting this therapy. Patients and Methods: 23 United States sites including Ambulatory Surgical Center Setting (ASC) and Outpatient Clinical settings. Respondents were physicians who had early experience with DEX in cataract surgery patients. This was a Phase 4 experiential cross-sectional survey study comprised of 3 sequential online physician surveys. Descriptive statistics summarized the surveys' responses to determine the early impressions of the respondents. Results: Forty-two physicians completed surveys. On average, physicians reported feeling comfortable administering DEX after placing 3 inserts (mean 2.7; standard deviation 1.9). Most physicians (92%) were satisfied with DEX, and all physicians (100%) reported that DEX improved patient compliance. Most physicians (62.5%) indicated they would highly prefer DEX over traditional steroid eyedrops for the management of post-surgical inflammation and pain. Conclusion: The surveys exploring the early use of DEX suggest that DEX is a clinically effective treatment with a rapid initial learning curve and integrates well into clinical use. Physicians had a very positive early experience with DEX, including comfort with insertion and satisfaction. DEX shows promise as a primary treatment choice of physicians for ocular inflammation and pain following cataract surgery by offering patients a hands-free innovative therapy that delivers a preservative-free steroid to the ocular surface over approximately 30 days.

5.
Clin Ophthalmol ; 16: 1829-1835, 2022.
Article in English | MEDLINE | ID: mdl-35702687

ABSTRACT

Purpose: To assess the change in corneal pachymetry after a novel epithelium-on (EpiSmart®) corneal crosslinking procedure (CXL). Methods: Eyes treated as part of the open-label, non-controlled arm of the study "Collagen Crosslinking with Ultraviolet-A in Asymmetric Corneas" (NCT01097447) were examined at baseline, 3-, 6- and 12-months post-CXL. Thinnest pachymetry readings based on Pentacam (OCULUS GmbH, Wetzlar, Germany) were recorded. Results: A total of 101 eyes met the study inclusion criteria. Thinnest pachymetric readings at baseline averaged 451 ± 50 microns. The mean (± SD) minimum thickness was 450 ± 46 microns at 3 months, 452 ± 47 microns at 6 months, and 451 ± 48 microns at 12 months post-CXL. The changes from baseline (mean ± SE) at 3, 6, and 12 months post-CXL were -1.2 ± 1.5 microns, 0.5 ± 1.6 microns, and 0.4 ± 1.6 microns, respectively. Student's t-tests showed no statistically significant change in pachymetry from baseline for any exam period. Conclusion: This study demonstrated that, after EpiSmart® epithelium-on CXL, there was no substantial corneal thinning observable on Scheimpflug tomography out to 12 months.

6.
Cornea ; 41(7): 917-920, 2022 Jul 01.
Article in English | MEDLINE | ID: mdl-34690271

ABSTRACT

PURPOSE: The purpose of this study was to describe infectious interface keratitis after Descemet membrane endothelial keratoplasty (DMEK) more than 2 years after surgery. METHODS: A case study. RESULTS: In this study, we report a case of fungal infectious interface keratitis occurring 2 years after uncomplicated Descemet membrane endothelial keratoplasty. The donor corneal rim culture at the time of surgery grew a single colony of Candida albicans/dubliniensis , but the patient was not treated with antifungals at that time. At the onset of clinical infection, more than 2 years postoperatively, the patient was treated with systemic antifungals and adjuvant intrastromal amphotericin-B injection. The patient subsequently required penetrating keratoplasty with ultimately well-preserved visual acuity. CONCLUSIONS: Fungal infectious interface keratitis (IIK) is a rare complication associated with lamellar keratoplasty. Although most common in the early postoperative period, this complication can occur several years after successful transplantation. Management may require a combination of systemic and stromal antifungal therapy. However, some patients may eventually require penetrating keratoplasty for definitive treatment.


Subject(s)
Descemet Stripping Endothelial Keratoplasty , Eye Infections, Fungal , Keratitis , Antifungal Agents/therapeutic use , Descemet Membrane/surgery , Descemet Stripping Endothelial Keratoplasty/adverse effects , Eye Infections, Fungal/diagnosis , Eye Infections, Fungal/drug therapy , Eye Infections, Fungal/etiology , Humans , Keratitis/diagnosis , Keratitis/drug therapy , Keratitis/etiology
7.
Pain Manag ; 12(1): 17-23, 2022 Jan.
Article in English | MEDLINE | ID: mdl-34164994

ABSTRACT

Pain and inflammation are common experiences following ocular surgery and, if uncontrolled, can compromise patients' vision, functioning and quality of life. Corticosteroid drugs are available to manage inflammation and discomfort but have limitations in penetrating the ocular mucus barrier to reach the target ocular tissues. KPI-121 1% (INVELTYS®) is a novel formulation of loteprednol etabonate that employs innovative proprietary technology to deliver nanoparticle-sized mucus-penetrating particles to the cornea. Results from clinical trials demonstrate that KPI-121 1% is effective and well tolerated. KPI-121 1% uses mucopenetrative technology for ophthalmic use and is the only US FDA-approved twice-daily ocular corticosteroid indicated for the treatment of inflammation and pain after ocular surgery.


Subject(s)
Anti-Allergic Agents , Quality of Life , Anti-Allergic Agents/therapeutic use , Humans , Inflammation/drug therapy , Intraocular Pressure , Pain/drug therapy , Postoperative Complications
8.
Cornea ; 40(8): 1018-1023, 2021 08 01.
Article in English | MEDLINE | ID: mdl-34029240

ABSTRACT

PURPOSE: The purpose of this study was to assess the impact of COVID-19 guidelines for corneal donor tissue screening and the utility of routine postmortem COVID-19 testing of donors intended for surgical use at a single eye bank. METHODS: A retrospective analysis of referrals to and eligible donors from an eye bank between March 1, 2020, and June 30, 2020, was performed, with the same time period in 2019 as a control. Referrals who were not procured because of Eye Bank Association of America COVID-19 guidelines and eye bank-specific restrictions were noted. The results of 1 month of routine postmortem testing performed by the eye bank were examined. Analysis of variance tests were performed to assess the change between donors from 2019 to 2020. RESULTS: There was a significant reduction in both the number of total referrals to the eye bank (P = 0.044) and donors eligible for surgical transplantation (P = 0.031). Eye Bank Association of America COVID-19 guidelines reduced the number of referrals over this period by 4% to 14%. Of the 266 surgically eligible donors who received postmortem COVID-19 testing in June by the eye bank, 13 resulted positive (4.9%). CONCLUSIONS: Despite a reduction in referrals and eligible corneal transplant donors at a single eye bank, there was a surplus of surgically suitable corneal tissue during the first wave of the COVID-19 pandemic. Eye banks should consider routine postmortem COVID-19 testing to identify asymptomatic infected donors although the risk of transmission of COVID-19 from infected donors is unknown.


Subject(s)
COVID-19/epidemiology , Cornea , Eye Banks/statistics & numerical data , Keratoplasty, Penetrating/statistics & numerical data , SARS-CoV-2 , Tissue Donors/supply & distribution , Tissue and Organ Procurement/standards , Adolescent , Adult , Aged , COVID-19 Nucleic Acid Testing , Corneal Diseases/surgery , Eye Banks/standards , Humans , Middle Aged , Practice Guidelines as Topic , Retrospective Studies
9.
Cornea ; 40(9): 1132-1140, 2021 Sep 01.
Article in English | MEDLINE | ID: mdl-33369937

ABSTRACT

PURPOSE: NOV03 has a unique dual mode of action to address dry eye disease (DED) associated with meibomian gland dysfunction. SEECASE evaluated the efficacy, safety, and tolerability of NOV03 at 2 dosing regimens compared with a saline comparator in patients with DED. METHODS: SEECASE was a prospective, multicenter, randomized, double-masked, saline-controlled clinical study. A total of 336 DED patients [tear film breakup time ≤5 seconds, abnormal meibum secretion, total corneal fluorescein staining (tCFS) score of 4 ≤ X ≤ 11 (National Eye Institute scale), Schirmer of ≥5 mm] were randomized in a 2:2:1:1 manner to NOV03 4 times daily (QID), NOV03 twice daily (BID), saline BID, and saline QID, respectively. The primary efficacy endpoint was tCFS staining at 8 weeks for both regimens. Secondary endpoints included visual analog scales and the Ocular Surface Disease Index questionnaire for symptom assessment. RESULTS: The study met its primary endpoint, change from baseline of tCFS over control, for both dosing regimens QID and BID (P < 0.001 and P = 0.009, respectively). NOV03 also showed pronounced improvement in various symptoms. For the Eye Dryness Score, changes from baseline were statistically significant compared with those of the control at week 8 [P < 0.001 (QID) and P = 0.002 (BID)]. Benefits on tCFS and symptoms started at 2 weeks after start of treatment and were maintained over the study duration. The effects were dosing schedule dependent. NOV03 was well tolerated with instillation site reactions below 3% in both treatment regimes. CONCLUSIONS: The SEECASE study demonstrated that NOV03 improves signs and symptoms in patients with highly symptomatic evaporative dry eye disease.


Subject(s)
Dry Eye Syndromes/drug therapy , Fluorocarbons/therapeutic use , Administration, Ophthalmic , Adult , Aged , Aged, 80 and over , Double-Blind Method , Dry Eye Syndromes/etiology , Dry Eye Syndromes/physiopathology , Female , Fluorescein/administration & dosage , Fluorocarbons/adverse effects , Fluorophotometry , Humans , Male , Meibomian Gland Dysfunction/complications , Middle Aged , Ophthalmic Solutions , Prospective Studies , Staining and Labeling/methods , Surveys and Questionnaires , Tears/physiology , Treatment Outcome , Visual Analog Scale , Young Adult
10.
Ocul Surf ; 19: 322-329, 2021 01.
Article in English | MEDLINE | ID: mdl-33176215

ABSTRACT

BACKGROUND: SARS-CoV-2 is found in conjunctival swabs and tears of COVID-19 patients. However, the presence of SARS-CoV-2 has not been detected in the human eye to date. We undertook this study to analyze the prevalence of SARS-CoV-2 in human post-mortem ocular tissues. METHODS: The expression of SARS-CoV-2 RNA was assessed by RT-PCR in corneal and scleral tissues from 33 surgical-intended donors who were eliminated from a surgical use per Eye Bank Association of America (EBAA) donor screening guidelines or medical director review or positive COVID-19 test. Ocular levels of SARS-CoV-2 RNA (RT-PCR), Envelope and Spike proteins (immunohistochemistry) and anti-SARS-CoV-2 IgG and IgM antibodies (ELISA) in blood were evaluated in additional 10 research-intent COVID-19 positive donors. FINDINGS: Of 132 ocular tissues from 33 surgical-intended donors, the positivity rate for SARS-CoV-2 RNA was ~13% (17/132). Of 10 COVID-19 donors, six had PCR positive post-mortem nasopharyngeal swabs whereas eight exhibited positive post-mortem anti-SARS-CoV-2 IgG levels. Among 20 eyes recovered from 10 COVID-19 donors: three conjunctival, one anterior corneal, five posterior corneal, and three vitreous swabs tested positive for SARS-CoV-2 RNA. SARS-CoV-2 spike and envelope proteins were detected in epithelial layer of the corneas that were procured without Povidone-Iodine (PVP-I) disinfection. INTERPRETATIONS: Our study showed a small but noteworthy prevalence of SARS-CoV-2 in ocular tissues from COVID-19 donors. These findings underscore the criticality of donor screening guidelines, post-mortem nasopharyngeal PCR testing and PVP-I disinfection protocol to eliminate any tissue harboring SARS-CoV-2 being used for corneal transplantation.


Subject(s)
Autopsy , COVID-19 , Conjunctiva/virology , RNA, Viral/isolation & purification , SARS-CoV-2/isolation & purification , Aged , Cornea/virology , Female , Humans , Male , Middle Aged , Prevalence , Vitreous Body/virology
11.
medRxiv ; 2020 Oct 06.
Article in English | MEDLINE | ID: mdl-33052357

ABSTRACT

BACKGROUND: SARS-CoV-2 is found in conjunctival swabs and tears of COVID-19 patients. However, the presence of SARS-CoV-2 has not been detected in the human eye to date. We undertook this study to analyze the prevalence of SARS-CoV-2 in human post-mortem ocular tissues. METHODS: The expression of SARS-CoV-2 RNA was assessed by RT-PCR in corneal and scleral tissues from 33 surgical-intended donors who were eliminated from a surgical use per Eye Bank Association of America (EBAA) donor screening guidelines or medical director review or positive COVID-19 test. Ocular levels of SARS-CoV-2 RNA (RT-PCR), Envelope and Spike proteins (immunohistochemistry) and anti-SARS-CoV-2 IgG and IgM antibodies (ELISA) in blood were evaluated in 10 COVID-19 donors. FINDINGS: Of 132 ocular tissues from 33 surgical-intended donors, the positivity rate for SARS-CoV-2 RNA was ~13% (17/132). Of 10 COVID-19 donors, six had PCR positive post-mortem nasopharyngeal swabs whereas eight exhibited positive post-mortem anti-SARS-CoV-2 IgG levels. Among 20 eyes recovered from 10 COVID-19 donors: three conjunctival, one anterior corneal, five posterior corneal, and three vitreous swabs tested positive for SARS-CoV-2 RNA. SARS-CoV-2 spike and envelope proteins were detected in epithelial layer of the corneas that were procured without Povidone-Iodine (PVP-I) disinfection. INTERPRETATIONS: Our study showed a small but noteworthy prevalence of SARS-CoV-2 in ocular tissues from COVID-19 donors. These findings underscore the criticality of donor screening guidelines, post-mortem nasopharyngeal PCR testing and PVP-I disinfection protocol to eliminate any tissue harboring SARS-CoV-2 being used for corneal transplantation.

12.
Am J Ophthalmol Case Rep ; 18: 100707, 2020 Jun.
Article in English | MEDLINE | ID: mdl-32368689

ABSTRACT

PURPOSE: To describe late-onset fungal keratitis after Descemet's stripping endothelial keratoplasty (DSEK) with positive fungal culture of the donor corneal rim. OBSERVATIONS: A case report of a patient undergoing DSEK is described whereby the donor corneal rim culture grew fungus. No infection was initially noted, but the patient developed fungal keratitis 1 year after the original DSEK procedure, despite prophylactic treatment at the time of the positive donor culture. The patient responded to antifungal therapy, but fungal keratitis recurred following completion of a 1-year course of antifungal treatment. The patient eventually underwent full thickness keratoplasty. CONCLUSIONS AND IMPORTANCE: A positive fungal culture of the donor rim tissue at the time of endothelial keratoplasty is a risk factor for fungal keratitis. Even with prophylactic antifungal treatment, fungal keratitis may eventually develop as late as 1 year after the initial endothelial keratoplasty procedure. Treatment may need to be aggressive, but keratitis may recur despite resolution with antifungal treatment.

13.
J Ocul Pharmacol Ther ; 36(7): 497-511, 2020 09.
Article in English | MEDLINE | ID: mdl-32391735

ABSTRACT

Dry eye disease (DED) is a common ocular condition that can impair vision and may adversely impact quality of life. Due to the inflammatory nature of this disorder, topical corticosteroids are an effective treatment option, particularly for moderate-to-severe DED when first-line treatments, such as ocular lubricants, are insufficient. Loteprednol etabonate (LE) is a retrometabolically designed corticosteroid with a low propensity to cause corticosteroid-related adverse effects, such as elevated intraocular pressure (IOP). This review was conducted to provide an assessment of published studies on the use of LE for treatment of inflammation associated with DED. Twelve prospective and 2 retrospective studies evaluating LE ophthalmic suspension 0.5% and 2 prospective studies evaluating LE ophthalmic gel 0.5% were identified. LE given as monotherapy or with artificial tears (AT) improved signs of DED, especially among patients with a more pronounced inflammatory component, and also improved DED symptoms compared to baseline and/or control. Treatment with LE before cyclosporine A (CsA) therapy reduced stinging upon CsA initiation and provided more rapid relief of DED signs and symptoms than CsA plus AT alone. In patients with meibomian gland dysfunction, LE alone, or in addition to eyelid scrubs/warm compresses, reduced clinical signs and symptoms, and tear proinflammatory cytokine levels. Overall, LE was safe and well tolerated, with minimal effects on IOP. While larger and longer-term studies are warranted, these data support the use of LE as a safe and effective treatment option for DED.


Subject(s)
Anti-Allergic Agents/administration & dosage , Dry Eye Syndromes/drug therapy , Loteprednol Etabonate/administration & dosage , Animals , Anti-Allergic Agents/adverse effects , Cyclosporine/administration & dosage , Cyclosporine/adverse effects , Dry Eye Syndromes/pathology , Humans , Inflammation/drug therapy , Inflammation/pathology , Loteprednol Etabonate/adverse effects , Lubricant Eye Drops/administration & dosage , Quality of Life
14.
Cornea ; 38(2): 177-182, 2019 Feb.
Article in English | MEDLINE | ID: mdl-30615600

ABSTRACT

PURPOSE: Descemet stripping endothelial keratoplasty (DSEK), currently the most common procedure for managing corneal endothelial dysfunction, may be repeated following DSEK failure from a variety of causes. This multicenter study reports the risk factors and outcomes of repeat DSEK. METHODS: This was an institutional review board-approved multicenter retrospective chart review of patients who underwent repeat DSEK. Twelve surgeons from 5 Midwest academic centers and 3 private practice groups participated. The Eversight Eye Bank provided clinical indication and donor graft data. We also assessed the role of the learning curve by comparing cohorts from the first and second 5-year periods. RESULTS: A total of 121 eyes from 121 patients who underwent repeat DSEK were identified. The average age of the patients was 70 ± 12 years. The most common indication for repeat DSEK was late endothelial graft failure without rejection (58%, N = 63). Average preoperative and 12-month postoperative repeat DSEK corrected distance visual acuities were 20/694 and 20/89, respectively. Visual acuity outcomes, endothelial cell density, and cell loss did not significantly vary between the 2 cohorts. Initial graft rebubble rates for the first and second cohorts were 51% and 25%. The presence of glaucoma, prior glaucoma surgery, or a history of penetrating (full thickness) keratoplasty did not significantly affect visual outcomes. The median, mean, and range of intraocular pressures before repeat DSEK were 15.0, 15.7, and 6 to 37 mm Hg, respectively. Patients with higher intraocular pressures before repeat DSEK had improved postoperative corrected distance visual acuities. CONCLUSIONS: Repeating DSEK improves vision following failed or decompensated DSEK surgery. Higher preoperative repeat DSEK IOPs were associated with improved visual outcomes, and initial graft rebubble rates, which decreased over time, were likely due to surgeon experience.


Subject(s)
Corneal Diseases/surgery , Descemet Stripping Endothelial Keratoplasty/methods , Aged , Aged, 80 and over , Corneal Diseases/physiopathology , Corneal Endothelial Cell Loss/etiology , Female , Graft Rejection/pathology , Humans , Intraocular Pressure/physiology , Male , Middle Aged , Reoperation , Retrospective Studies , Risk Factors , Visual Acuity/physiology
15.
Clin Ophthalmol ; 12: 263-270, 2018.
Article in English | MEDLINE | ID: mdl-29440868

ABSTRACT

PURPOSE: To evaluate ocular comfort of lifitegrast ophthalmic solution 5.0% among patients with dry eye disease (DED) in the OPUS-3 trial. METHODS: OPUS-3 was a multicenter, randomized, double-masked, placebo-controlled study. Adults with DED and recent artificial tear use were randomized 1:1 (lifitegrast:placebo) to ophthalmic drops twice daily for 84 days. On days 0 (baseline), 14, 42, and 84, drop comfort score (scale, 0-10; 0 = very comfortable, 10 = very uncomfortable) was measured at 0, 1, 2, and 3 minutes postinstillation. If the score was >3 at 3 minutes, assessment was repeated at 5, 10, and 15 minutes until score ≤3. Ocular treatment-emergent adverse events (TEAEs) were assessed. RESULTS: Overall, 711 participants were randomized (n=357 received lifitegrast; n=354 received placebo). Drop comfort scores for lifitegrast-treated participants improved within 3 minutes of instillation (mean scores on day 84 for both study and fellow eyes: instillation: lifitegrast, 3.4, placebo, 1.0; 3 minutes: lifitegrast, 1.5, placebo, 0.7). The majority (64%-66%) of participants had scores <3 within 3 minutes postinstillation on days 14, 42, and 84. In participants with scores >3 at 3 minutes, the mean score in the lifitegrast group was similar to or better than that in the placebo group at 5, 10, or 15 minutes postinstillation. Lifitegrast appeared to be well tolerated, with ocular TEAEs rarely leading to discontinuation. CONCLUSION: In OPUS-3, lifitegrast appeared to be well tolerated and drop comfort scores approached placebo levels by 3 minutes postinstillation.

16.
Clin Ophthalmol ; 11: 1883-1889, 2017.
Article in English | MEDLINE | ID: mdl-29089744

ABSTRACT

PURPOSE: Artificial tears are the first line of therapy for dry eye disease (DED) and are also the most frequently used treatment approach for this common condition. Despite this, there are few published studies that directly compare the effectiveness of different drop preparations, especially those formulated specifically for dry eye. In this study, we tested a new artificial tear product, Rohto® Dry-Aid™, for its ability to relieve the signs and symptoms of DED. The study used a second drop, Systane® Ultra, as a positive comparator. MATERIALS AND METHODS: This was a prospective, single-center, open-label, parallel-group study comparing the effects of the two products when used continuously over ~30 days (Clinical Trials registration number NCT03183089). Subjects were randomly assigned to one of the two test groups and were monitored 2 and 4 weeks after enrollment. Efficacy endpoints included ocular staining, visual function, and ocular discomfort. RESULTS: Treatment groups had similar ocular staining and ocular comfort scores, and both showed statistically significant ocular discomfort score improvement. Subjects in the Rohto group reported significant improvements in visual tasking activities such as watching television and driving at night. There was also a tendency for diary symptom scores to worsen from morning to evening in the Systane group, but not in the Rohto group; this trend was not significant, but warrants further study. CONCLUSION: The two products, Rohto Dry-Aid and Systane Ultra, elicited comparable effects on the signs and symptoms of DED. While both products are designed to provide long-lasting relief, subjects in the Rohto group experienced a superior relief from discomfort associated with visual tasking activities and daily diaries, indicating that the Rohto drops may provide a longer duration of symptomatic relief over the course of the day.

17.
Cornea ; 36(12): 1556-1558, 2017 Dec.
Article in English | MEDLINE | ID: mdl-28976414

ABSTRACT

PURPOSE: To report the successful medical management of a late-onset Descemet membrane endothelial keratoplasty (DMEK)-related interface infection. METHODS: A case of DMEK endothelial keratoplasty-related infection treated with intrastromal antifungal injection was identified. The following information was collected: demographic data, surgical indications, donor rim cultures, donor mate outcomes, clinical course, diagnostic tests, and clinical outcome. RESULTS: A DMEK patient developed a single infiltrate approximately 1 month after uncomplicated DMEK. Donor rim culture was positive for Candida glabrata but no prophylactic treatment was initiated. Anterior segment optical coherence tomography confirmed the location of the infiltrate, and the patient was treated with oral fluconazole and an intrastromal injection of amphotericin B with an inadvertent, but negligible, intracameral volume of the same drug. The lesion significantly regressed on examination 2 days later with complete involution and excellent visual acuity to date. CONCLUSIONS: Medical therapy, including systemic and intrastromal application, is a viable initial treatment option for late-onset, presumed yeast interface keratitis in patients who have undergone DMEK.


Subject(s)
Amphotericin B/administration & dosage , Antifungal Agents/administration & dosage , Candidiasis/drug therapy , Eye Infections, Fungal/drug therapy , Postoperative Complications/drug therapy , Amphotericin B/therapeutic use , Candida glabrata/isolation & purification , Chemotherapy, Adjuvant , Descemet Stripping Endothelial Keratoplasty/adverse effects , Drug Therapy, Combination , Female , Fluconazole/administration & dosage , Humans , Injections, Intraocular , Middle Aged
18.
Clin Ophthalmol ; 11: 1423-1430, 2017.
Article in English | MEDLINE | ID: mdl-28848324

ABSTRACT

PURPOSE: To determine the incidence and severity of dry eye as determined by the International Task Force (ITF) scale in patients being screened for cataract surgery. PATIENTS AND METHODS: This was a prospective, multi-center, observational study of 136 patients, at least 55 years of age, who were scheduled to undergo cataract surgery. The primary outcome measure was the incidence of dry eye as evaluated by grade on the ITF scale and secondary outcome measures include tear break-up time (TBUT), ocular surface disease index score, corneal staining with fluorescein, conjunctival staining with lissamine green, and a patient questionnaire to evaluate symptoms of dry eye. RESULTS: Mean patient age was 70.7 years. A total of 73.5% of patients were Caucasian and 50% were female. Almost 60% had never complained of a foreign body sensation; only 13% complained of a foreign body sensation half or most of the time. The majority of patients (62.9%) had a TBUT ≤5 seconds, 77% of eyes had positive corneal staining and 50% of the eyes had positive central corneal staining. Eighteen percent had Schirmer's score with anesthesia ≤5 mm. CONCLUSION: The incidence of dry eye in patients scheduled to undergo cataract surgery in a real-world setting is higher than anticipated.

19.
J Cataract Refract Surg ; 43(1): 131-135, 2017 01.
Article in English | MEDLINE | ID: mdl-28317666

ABSTRACT

A 41-year-old man presented 10 years after uneventful laser in situ keratomileusis (LASIK) with symptomatic post-LASIK ectasia. He had treatment with the classic Dresden epithelium-off technique and presented 4 years later with progression of the ectasia. He was subsequently retreated with conductive keratoplasty (CK) followed by a new proprietary epithelium-on corneal collagen crosslinking (CXL) procedure using a proprietary transepithelial riboflavin formulation and delivery system on the following day. One year after retreatment, the patient noted stable vision in the treated eye with a corrected distance visual acuity (CDVA) of 20/60+. Thus, epithelium-on CXL, if performed with appropriate formulations and delivery technology as well as careful attention to appropriate riboflavin loading of the stroma, can stabilize an ectatic cornea. In addition, when performed prior to CXL, CK can induce a significant, lasting improvement in corneal shape and CDVA. This technique merits further study.


Subject(s)
Corneal Diseases , Keratomileusis, Laser In Situ , Adult , Collagen , Cornea , Corneal Diseases/therapy , Dilatation, Pathologic , Humans , Keratomileusis, Laser In Situ/methods , Male , Retreatment , Riboflavin/administration & dosage , Visual Acuity
20.
Curr Opin Ophthalmol ; 27 Suppl 1: 3-47, 2017 Jan.
Article in English | MEDLINE | ID: mdl-28099212

ABSTRACT

Dysfunctional tear syndrome (DTS) is a common and complex condition affecting the ocular surface. The health and normal functioning of the ocular surface is dependent on a stable and sufficient tear film. Clinician awareness of conditions affecting the ocular surface has increased in recent years because of expanded research and the publication of diagnosis and treatment guidelines pertaining to disorders resulting in DTS, including the Delphi panel treatment recommendations for DTS (2006), the International Dry Eye Workshop (DEWS) (2007), the Meibomian Gland Dysfunction (MGD) Workshop (2011), and the updated Preferred Practice Pattern guidelines from the American Academy of Ophthalmology pertaining to dry eye and blepharitis (2013). Since the publication of the existing guidelines, new diagnostic techniques and treatment options that provide an opportunity for better management of patients have become available. Clinicians are now able to access a wealth of information that can help them obtain a differential diagnosis and treatment approach for patients presenting with DTS. This review provides a practical and directed approach to the diagnosis and treatment of patients with DTS, emphasizing treatment that is tailored to the specific disease subtype as well as the severity of the condition.


Subject(s)
Dry Eye Syndromes , Eyelid Diseases/physiopathology , Meibomian Glands/physiopathology , Tears/physiology , Blepharitis/diagnosis , Blepharitis/physiopathology , Blepharitis/therapy , Dry Eye Syndromes/diagnosis , Dry Eye Syndromes/physiopathology , Dry Eye Syndromes/therapy , Humans , Keratoconjunctivitis Sicca/diagnosis , Keratoconjunctivitis Sicca/physiopathology , Keratoconjunctivitis Sicca/therapy
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