Comparison of the effect of three different ophthalmic viscosurgical devices used in eye surgery
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2022/02/040026
- Lead Sponsor
- The Eye Foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Unilateral/Bilateral cataract
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.Given consent to use device related data for scientific purpose.
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 (Random blood sugar level more than 140 mg/dl).
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
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Endothelial Cell Count Change from Baseline. <br/ ><br>Intraocular Pressure (IOP) Change from BaselineTimepoint: Pre-operative, 1-day, 2-Week, 1-month, 3-month <br/ ><br>post-surgery
- Secondary Outcome Measures
Name Time Method Change in Corneal thickness in millimeter (mm) <br/ ><br>Cell Hexagonality in percentage <br/ ><br>Corneal Clarity <br/ ><br>CV in cell size in percentage <br/ ><br>Cell area in ð???m2 <br/ ><br>Intraocular Inflammation with Grade of Inflammation <br/ ><br>Timepoint: Pre-operative , 2-Week, 1-month, 3-month post-surgery;Investigator Reported Space MaintenanceTimepoint: During surgical procedure