A prospective, randomized controlled, open-label, three-arm clinical study to compare and evaluate the clinical outcomes of three different Ophthalmic Viscoelastic devices (OVDs) used during the ophthalmic surgery to protect corneal endothelial cells and maintain anterior chamber space in patientsâ?? eye.

Biotech Vision Care Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Unilateral/Bilateral
•2. Patients with age >= 45 years.
•3. Patients with Grade I to III cataract and used OVDs
•4. Patients that have healthy eyes excluding the formation of cataract.
•5. A patient who had attended all the regular follow-up examinations as per the routine schedule and follow Protocol Schedule.
•6. A patient who are able to provide written informed consent

•1. Black, Brunescent, traumatic or subluxated cataract.
•2. Corneal endothelial disease.
•3. Pregnant lady and lactating mother
•4. Patient who is part of another device or drug trial.
•5. Baseline endothelial cell density < 1500 cells/mm2 in the operative eye.
•6. Patient who had Glaucoma, Pseudo exfoliation Syndrome with Iris atrophy, Proliferative diabetic retinopathy at the time of surgery.
•7. A history of chronic or recurrent inflammatory eye disease (e.g. iritis, scleritis, uveitis, Iridocyclitis, rubeosis iritis).
•8. Previous intra ocular or corneal surgery

发起方

Biotech Vision Care Pvt Ltd