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Optimisation of ocular surface with a gel of trehalose, hyaluronic acid plus carbomer in patients undergoing phacoemulsification: a randomised open-label study

Poster Details

First Author: A.López Masegosa SPAIN

Co Author(s):    J. Solana Fajardo   M. Jerez Fidalgo   F. Gonzalez Gonzalez              

Abstract Details

Purpose:

This randomized open-label study assessed the efficacy and safety of the addition of a gel of trehalose, hyaluronic acid plus carbomer (THC) to usual care (UC) during (Phase 1) and after (Phase 2) cataract surgery in patients with age-related cataracts and a diagnosis before surgery of mild-moderate dry eye, who had been scheduled for phacoemulsification

Setting:

The study was conducted in the Ophthalmology Department of the Hospital Perpetuo Socorro (Badajoz, Spain) from March to May 2017.

Methods:

42 patients (61-90 years), were randomly assigned to receive THC+UC (n=21) or UC alone (n=21). UC comprised preoperative topical mydriatics, and after surgery administration of dexamethasone eye drops every 2 hours, progressively down-titrated, for 30 days, and ciprofloxacin eye drops every 4 hours for 5 days. Patients in the THC+UC group received 2 drops of THC gel before surgery and 1 drop/8 hours after surgery for 30 days. Outcomes: number of intraocular irrigations with balanced salt solution (BSS) and duration (minutes) of surgery, and change in the ocular surface disease index (OSDI©) and the tear film break-up time (TBUT).

Results:

THC+UC vs. UC showed reduced number (mean±standard deviation) of intraocular irrigations with BSS (9.7±1.4 vs. 15.0±1.4;estimated treatment difference [ETD] -5.3, 95%CI-6.2 to -4.4);p<0.0001) and no difference in the duration of surgery. TBUT (seconds) increased in the THC+UC and decreased with UC (4.0±1.8 vs. -2.0±0.8;ETD 6.0, 95%CI 5.1 to 6.9;p<0.0001); OSDI score decreased in the THC+UC and increased with UC (-7.3±2.3 vs. 7.2±3.5;ETD -14.5, 95%CI -16.3 to -12.7;p<0.0001). Two patients with THC+UC gel and 10 patients with UC exhibited punctate keratitis after surgery (relative risk 0.20, 95%CI 0.05 to 0.81;p= 0.0235).

Conclusions:

The addition of THC gel to usual care before and after phacoemulsification compared to usual care alone reduces corneal opacity during surgery, and improves tear film stability and dry eye symptoms after surgery. THC gel also reduces the risk of punctate keratitis.

Financial Disclosure:

None

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