Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: EYEVISCâ?¢ 2%: Hydroxypropyl Methylcellulose 2% (Biotech Vision Care Pvt. Ltd.)
Used intraoperatively injected into the anterior chamber during intraocular surgery
Control Intervention1
Sponsors
The Eye Foundation
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Endothelial Cell Count Change from Baseline. Intraocular Pressure (IOP) Change from BaselineTimepoint: Pre-operative, 1-day, 2-Week, 1-month, 3-month post-surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Corneal thickness in millimeter (mm) Cell Hexagonality in percentage Corneal Clarity CV in cell size in percentage Cell area in ð???m2 Intraocular Inflammation with Grade of Inflammation Timepoint: Pre-operative , 2-Week, 1-month, 3-month post-surgery;Investigator Reported Space MaintenanceTimepoint: During surgical procedure | — |
Countries
India
Contacts
Public ContactShreyas Ramamurthy
The Eye Foundation
Outcome results
None listed