A study to evaluate the safety profile of phacoemulsification on corneal endothelium in different grades of cataract

Phase 4

Completed

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

• Registration Number: CTRI/2019/10/021696
• Lead Sponsor: Regional Institute of Ophthalmology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-07-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 195

Inclusion Criteria

Patients with senile cataract undergoing phacoemulsification at Regional Institute of Ophthamalology, Pt. B. D. Sharma PGIMS, Rohtak.

Exclusion Criteria

1.Patient with history of diabetes

2.Previous corneal disease, corneal

trauma, intraocular surgery

3.Pseudoexfoliation syndrome

4.Co-existent glaucoma

5.Corneal endothelial dystrophy

6.Intraoperative complications- PCR,

vitreous loss, iris trauma, descemetâ??s

detachment

7.Uveitis

8.Anterior chamber depth less than 2 mm

9.Patient refusing to give consent for the

study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Status of corneal endothelium in terms of endothelial cell loss, endothelial cell morphology and corneal thickness before and after phacoemulsification using specular microscopy in different grades of cataract.Timepoint: Data will be recorded before surgery,post-op day 1, 1st week post-operatively and 4th week post-operatively. After the collection and compilation of data, appropriate statistical test will be used to analyse the results.

Secondary Outcome Measures

Name	Time	Method
Status of corneal endothelium in terms of endothelial cell loss, endothelial cell morphology and corneal thickness before and after phacoemulsification using specular microscopy in different grades of cataract.Timepoint: Data will be recorded before surgery,post-op day 1, 1st week post-operatively and 4th week post-operatively. After the collection and compilation of data, appropriate statistical test will be used to analyse the results.