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Biocompatibility and stability assessment of a novel corneal gel for ophthalmic surgery

Poster Details

First Author: P.Giardini ITALY

Co Author(s):    A. Esdras   M. Aguilar   V. Sargent   J. Parel   C. Gatto   J. Damato Tothova     

Abstract Details

Purpose:

EYEDRO is a novel corneal gel intended to maintain corneal hydration, epithelial integrity and corneal clarity during ophthalmic surgery procedures. The aim of the present study was to assess the biocompatibility of EYEDRO clinically and histologically and to test its physical and optical performances in vivo.

Setting:

Experimental design: Alchilife Srl. Experiment execution: University of Miami Miller School of Medicine, Department of Ophthalmology/Ophthalmic Biophysics Center/Bascom Palmer Eye Institute, Miami, USA

Methods:

Corneal surface of eyes of 12 New Zealand White rabbit was covered with Eyedro gel (AL.CHI.MI.A. S.r.l.). Controlateral eyes served as control. 6 treated eyes were used for slit-lamp (Topcon SL7) examination, intraocular pressure (IOP) measurements (Perkin Clement Clark International), and ultrasonic pachymetry (DGH 500 Pachette), 1, 3 and 7 day post-op (POD). The other 6 eyes were used to test physical stability of gel by recording a video for 60 min. after gel application. Histological analysis by Hematoxylin/eosin, periodic acid-Shiff and Masson Trichrome stains was performed in 12 eyes.

Results:

No hyperemia or anterior chamber inflammatory reaction was observed. Mean IOP was always comparable to that of control group. Cornea and conjunctiva were normal in all eyes at POD 1, POD 3 and POD 7. At POD 7, gonioscopy was normal in all eyes, and retinal funduscopy showed no negative clinical signs in the anterior chamber, lens, vitreous or retina. Mean ultrasonic pachymetry ranged from 365.3 ±16.1 μm (POD0) to 357.7 ±10.9 μm (POD7). Gel was stable with optimal optical clarity, unchanged appearance and transparency during the whole test period. Histology showed no tissue damage.

Conclusions:

EYEDRO gel was easy to apply and exhibited an excellent long-term biocompatibility in rabbits. No adverse effects were observed and optimal transparency of gel, and corneal clarity and hydration for at least 60 minutes after application were observed.

Financial Disclosure:

One or more of the authors receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented, One or more of the authors research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented

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