To compare and evaluate clinical outcome of three different ophthalmic viscoelastic devices during ophthalmic surgery

Phase 4

• Conditions: Health Condition 1: H251- Age-related nuclear cataract

• Registration Number: CTRI/2020/02/023391
• Lead Sponsor: Biotech Vision Care Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Endothelial Cell Count Change from Baseline, <br/ ><br> <br/ ><br>Intraocular Pressure (IOP) Change from BaselineTimepoint: Time Frame: Pre-operative, 1-day, 2-Week , 1-month, 3-month and 6-months post-surgery <br/ ><br> <br/ ><br>Intraocular Pressure (IOP) Change from Baseline

Secondary Outcome Measures

Name	Time	Method
Investigator Reported Space Maintenance, <br/ ><br> <br/ ><br>Change in Corneal thickness in millimeter (mm), <br/ ><br> <br/ ><br>Intraocular Inflammation with Grade of Inflammation, <br/ ><br> <br/ ><br>Corneal Clarity, <br/ ><br> <br/ ><br>CV in cell size in percentage, <br/ ><br> <br/ ><br>Cell area in ð???m2, <br/ ><br> <br/ ><br>Cell Hexagonality in percentage, <br/ ><br> <br/ ><br>Adverse EventsTimepoint: Pre-Operative to 1-day, 2-Week , 1-month, 3-months and 6-months post-surgery