Comparative Study Of Surgical Outcomes Using Different Viscoelastic Agents In Topical Phacoemulsification Among Diabetic Patients With Cataracts At A Tertiary Care Centre
Overview
- Phase
- Phase 3 4
- Status
- Not yet recruiting
- Sponsor
- Datta Meghe Institute of Higher Education and Research
- Enrollment
- 174
- Locations
- 1
- Primary Endpoint
- Postoperative corneal endothelial cell loss associated with different viscoelastic agents
Overview
Brief Summary
This is a prospective, comparative, open-label interventional study to evaluate surgical outcomes of different viscoelastic agents in topical phacoemulsification among diabetic patients with cataract at a tertiary care centre. A total of 174 patients (87 in each group) will be included. Group 1 will receive Sodium Hyaluronate Ophthalmic Solution (Hyloject) and Group 2 will receive Hypromellose Ophthalmic Solution USP (Hyprosol) during cataract surgery. The primary outcome is postoperative corneal endothelial cell loss. Secondary outcomes include visual recovery, intraocular pressure changes, and postoperative complications. The study duration will be 2 years.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 40.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Patients with senile cataract and diagnosed diabetes mellitus.
- •2.Patients willing to give informed consent.
Exclusion Criteria
- •1.Preoperative glaucoma or IOP more than 20 mmHg. 2.Intraoperative complications like manual dilatation of pupil, posterior capsular rent, sulcus IOL placement.
- •3.Presence of subluxation, pseudoexfoliation, or other associated ocular/corneal pathology.
- •4.Previous intraocular surgery in study eye.
Outcomes
Primary Outcomes
Postoperative corneal endothelial cell loss associated with different viscoelastic agents
Time Frame: Pre-Operative, Post-Operative Day 1, Day 15, and 1 Month
Secondary Outcomes
- Visual Acuity (Both Uncorrected and Corrected Visual Acuity)(Pre-Operative, Post-Operative Day 1, Day 15, and 1 Month)
- Intraocular Pressure (IOP) Changes(Pre-Operative, Post-Operative Day 1, Day 15, and 1 Month)
- Postoperative Complications Related To Viscoelastic Agents(Post-Operative Day 1, Day 15, and 1 Month)
Investigators
Dr Savsani Varnil Rajeshbhai
Datta Meghe Institute of Higher Education & Research