Evaluating the Safety of Femtosecond Laser assisted Cataract Surgery (FLACS) and comparing it with Phacoemulsification Cataract Surgery (Phaco) in the hands of Junior Cataract Surgeons.

Completed

• Conditions: Unspecified age-related cataract,

• Registration Number: CTRI/2018/12/016584
• Lead Sponsor: Alcon Laboratiores Inc

Brief Summary

We wish to propose a Randomized, MaskedClinical Trial comparing FLACS and Phaco in terms of its postoperative safetyoutcomes – corneal thickness, corneal edema, anterior chamber cells and flare,corneal endothelial cell count and morphology and macular thickness, in thehands of a junior cataract surgeon.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-20
• Study Completion: 2021-06-30
• Last Update Posted: 2023-07-15

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

• Uncomplicated age related cataracts, Nuclear Opalescence(NO) grade I to IV(LOCS III classification).
• Only one eye of each patient will be included.

Exclusion Criteria

Ocular comorbidity, glaucoma, uveitis, previous ocular trauma or surgery, pseudoexfoliation, traumatic cataract, subluxated cataract.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Central Corneal Thickness, Corneal edema, Anterior Chamber Inflammation (anterior chamber cells and flare) at 1 day, 1 week and 1 month postoperatively	1 day, 1 week and 1 month

Secondary Outcome Measures

Name	Time	Method
Macular thickness at 1 month and 3 months, Corneal endothelial cell count and morphology at 6 months postoperatively, Visual Acuity (uncorrected and corrected) at 1 day, 1 week and 1, 3 months postoperatively	1 day, 1 week, 1 month, 3 months and 6 months.

Trial Locations

Locations (1)

Raghudeep Eye Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Raghudeep Eye Hospital

🇮🇳Ahmadabad, GUJARAT, India

Abhay Vasavada

Principal investigator

0917927490909

icirc@abhayvasavada.com