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Fluorometholone for Protecting the Ocular Surface in Dry Eye
January 2016
In this double-masked trial, Pinto-Fraga et al. evaluated the clinical efficacy of the topical corticosteroid fluorometholone (FML) in dry eye disease (DED) and examined whether it could protect the ocular surface against exposure to adverse environments. They found that, indeed, FML was effective in reducing DED signs and preventing exacerbation caused by dessicating stress.
This study consisted of 4 visits by 41 DED patients over a 22-day period. All patients were randomly selected to receive 1 drop 4 times daily of either topical 0.1% FML or topical polyvinyl alcohol (PA) for 22 days. The researchers assessed corneal and conjunctival staining, conjunctival hyperemia, tear film breakup time (TBUT), tear osmolarity, and Symptom Assessment in Dry Eye scores at 4 time points: at baseline, on day 21 before and after 2-hour exposure to an adverse environment (counted as 2 visits), and on day 22.
The researchers found that after 21 days of treatment, the FML group had greater improvements in corneal and conjunctival staining, hyperemia, and TBUT than the PA group. The FML group also showed no significant changes in staining and hyperemia after exposure to adverse conditions, whereas the PA group experienced significant worsening in these variables. Further, the percentage of patients with at least a 1-grade increase in corneal staining was significantly higher in the PA group after exposure.
The researchers concluded that, based on these results, FML therapy could be a suitable prophylactic approach for DED patients who expect to experience an environmental stress.
Outcomes of Cataract Surgery in Uveitic Eyes
January 2016
Sen et al. assessed the visual outcomes of cataract surgery for patients in the Multicenter Uveitis Steroid Treatment (MUST) trial. They found that the surgery substantially improved vision, whether the uveitis was being treated with an intraocular steroid implant or with standard systemic therapy.
This prospective cohort study included 117 eyes from 82 patients who underwent cataract surgery during follow-up in the MUST trial—a clinical study comparing a fluocinolone implant with systemic corticosteroids and immunosuppressive medications for the treatment of noninfectious uveitis. Visual outcomes were evaluated at 3, 6, and 9 months after cataract surgery.
Of the 117 eyes, 28 (24%) received systemic therapy and 89 (76%) received an implant. The researchers found no significant difference in visual acuity (VA) improvement between the treatment groups. For all eyes, VA increased by 23 letters from the preoperative visit to the 3-month visit and remained stable through 9 months of follow-up. African-American race, longer duration of uveitis, and hypotony were all associated with worse preoperative VA but did not affect postsurgical recovery.
Because a large majority of eyes showed an improvement in VA, the researchers were limited in their ability to perform multivariate analyses of risk factors related to VA.
Safety of E10030 and Ranibizumab for AMD
January 2016
Jaffe et al. assessed the combination of E10030 (Fovista), a platelet-derived growth factor, and the anti-VEGF agent ranibizumab to treat age-related macular degeneration (AMD). They found that the therapy was safe and well tolerated, with no evidence of systemic or ocular toxicity.
For this phase 1 clinical trial, the researchers enrolled 23 patients aged 50 years or older who had a diagnosis of AMD. Part 1 of the study included 15 patients. Three received a single intravitreal E10030 (0.03 mg) injection and then a subsequent intravitreal ranibizumab (0.5 mg) injection at weeks 2, 6, and 10. Once the safety of the combination doses was established, 12 additional patients then received E10030 (0.03, 0.3, 1.5, or 3.0 mg) in combination with ranibizumab (0.5 mg) at day 0 and months 1 and 2. Part 2 then consisted of 8 additional patients who received E10030 (0.3, 1.5, or 3.0 mg) with ranibizumab (0.5 mg) at day 0 and months 1 and 2. The primary outcome measure for the trial was safety at week 12.
All doses of E10030 administered with ranibizumab were well tolerated, and no dose-limiting toxicities or relevant safety events were noted. Mean change in visual acuity for the combination therapy was a gain of 14 letters, and 59% of participants gained at least 15 letters from baseline at week 12. On fluorescein angiography at week 12, there was an 85.5% mean reduction from baseline in choroidal neovascularization size. In addition, optical coherence tomography at week 12 showed a mean decrease in center point thickness and central subfield thickness of 38.9% and 33.7%, respectively.
Reoperation and Retinal Detachment Following Macular Hole Surgery
January 2016
In this retrospective, cross-sectional study, Vaziri et al. evaluated the risks of macular hole surgery and found that rates of reoperation and postoperative retinal detachment (RD) were both low. They also noted that patients receiving internal limiting membrane (ILM) peeling were less likely to undergo reoperation or experience postsurgical complications.
Using CPT and ICD-9 codes obtained from the MarketScan claims database, the researchers identified 23,465 macular hole surgeries among 20,764 patients. Of these patients, 6,929 were male and 13,835 were female. Ages ranged from 3 to 99 years (mean, 65.2 ± 9.9 years). Main outcome measures for the study included rates of reoperation and postoperative RD at 2, 3, and 12 months after surgery, including a subgroup analysis based on the presence or absence of ILM peeling.
Because many records did not designate the operated eye, the researchers grouped the cases into 2 categories. “Presumed” reoperations included all macular hole surgeries, regardless of whether eye laterality was specified. The “definite” category was a subset that included only those cases in which the surgical record specified that the same eye underwent subsequent operation.
In the “presumed” group, the reoperation rates were the following: within 2 months after surgery, 4.1% with ILM peeling and 5.0% without peeling; within 3 months, 5.3% with ILM peeling and 6.2% without peeling; and within 12 months, 9.0% with ILM peeling and 11.0% without peeling. In the “definite” group, the reoperation rates were the following: within 2 months of surgery, 1.2% with ILM peeling and 1.8% without peeling; within 3 months, 1.6% with ILM peeling and 2.5% without peeling; and within 12 months, 3.3% with ILM peeling and 7.5% without peeling. The cumulative rate of postoperative RD was 1.81% to 2.18% after 2 months, 2.27% to 3.18% after 3 months, and 3.92% to 5.70% after 12 months. ILM peeling was negatively associated with RD at all of these time points.
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Ophthalmology summaries are written by Michael Mott and edited by Susan M. MacDonald, MD.
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