An Update from the ASCRS 2018 Annual Meeting

DREAM Trial
The Dry Eye Assessment and Management (DREAM) trial was designed to provide comprehensive information on the effects of n–3 fatty acid supplementation on dry eye disease. It was a double-masked, randomized, multicenter clinical trial. The trial included 535 patients with moderate-to-severe dry eye disease randomized 2:1 into a treatment group (daily oral dose of 3000 mg of fishderived n–3 eicosapentaenoic and docosahexaenoic acids) or a placebo (5000 mg refined olive oil) group. The primary outcome was the mean change from baseline in the score on the Ocular Surface Disease Index. Secondary outcomes included mean changes per eye in the conjunctival staining score and the corneal staining score.

The mean change in the OSDI score was not significantly different between the active supplement group and the placebo group (–13.9 points and –12.5 points), respectively. There were no significant differences between the active supplement group and the placebo group in mean changes from baseline in the conjunctival staining score, corneal staining score, tear break-up time, and result on Schirmer’s test. These 1-year results were presented by Penny Asbell during Cornea Day at ASCRS 2018.

Post LASIK ectasia
Steven Schallhorn presented the results of an ongoing analysis of a cohort of 200000 patients who underwent LASIK between 2007-2011. 213 eyes of 155 patients developed ectasia. Univariate analysis found corneal steepness and asymmetric bow tie not to be related to ectasia. Multivariate analysis found forme fruste keratoconus alone had 20 times the risk for ectasia development, a 1 in 160 chance.

40% occurred in patients older than 30 years, and 98% of patients had 8 D or less of myopia. Central cornea thickness greater than 510 μm was present in 80% of cases, and residual stromal bed greater than 300 μm occurred in 88%. Thirty percent of ectatic patients had normal topography. The two greatest risk factors were abnormal corneal shape and younger age.

Hydrogel sealant
Leon Herndon Jr. at the Glaucoma Day presented the results of the clinical trial on ReSure sealant (Ocular Therapeutix) in a wide variety of combination phaco/glaucoma procedures. A wound challenge test was conducted in 487 patients at 24 U.S. sites, found wound leakage rates of 4.1% in those in whom the hydrogel sealant was used, in contrast to 34.1% of patients with sutures.

Choice of dry eye diagnostics
John Sheppard during his lecture at Cornea Day, encouraged the use of those tests which are backed with scientific evidence in the decision making and management of DED. He recommended meibography, osmolarity and MMP-9 as invaluable tools in the decision-making process. MMP-9 testing is a useful marker for whether a patient should be treated with an anti-inflammatory, and osmolarity testing can screen out patients who will have unpredictable biometry before cataract surgery.

PROSE lens
Bryan Roth presented the results of a study aimed at assessing the impact of PROSE use on visual acuity. The retrospective chart review analyzed 825 eyes of 490 patients who were fit with the lens at Baylor College of Medicine from 2010 to 2016 for either distorted, irregular cornea or ocular surface disease. In both categories, PROSE statistically significantly improved visual acuity from pre-PROSE values (both P < .001).

When the irregular cornea group was broken down into subcategories of corneal scars and dystrophies, postsurgical irregularity and primary ectasia etiologies, statistically significant improvement was seen in each group. Similarly, there was statistically significant improvement in each sub-etiology of ocular surface disease, including dry eye syndrome, limbal stem cell deficiency, neurotrophic keratopathy, corneal exposure, graft vs. host disease and Stevens-Johnson syndrome.

He concluded that PROSE should be considered in patients who have failed other conservative treatment measures or in patients who desire improvement in visual acuity without surgical intervention.

Cyclosporine A formulation
Jodi Luchs reported the results of a phase 3 study assessing the ocular safety, tolerability and efficacy of OTX-101 (Sun Pharmaceutical Industries), a cyclosporine A 0.09% formulation, compared with vehicle when dosed for 84 days in subjects with keratoconjunctivitis sicca. The study was randomized 1:1 with 372 patients in each group.

Efficacy was statistically significantly better in the treatment arm (P < .0001) compared with the vehicle arm as demonstrated by percent of eyes with 10 mm or more increase from baseline in Schirmer’s test score, which was the primary efficacy endpoint. Total conjunctival  staining score, a secondary endpoint, was statistically significantly better than vehicle (P = .0007) as well. The overall incidence of adverse events was low.