Cataract Surgery in Indian Patients With or Without LenSx® Laser

Withdrawn

• Conditions: Cataracts
• Interventions: Device: LenSx® laser system; Procedure: Phacoemulsification

• Registration Number: NCT02605408
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study is to record and analyze the profile and outcome of cataract patients receiving phacoemulsification (phaco) and artificial intraocular lens (IOL) implantation with or without femtosecond laser-assisted cataract surgery (FLACS) in Indian tertiary medical centers.

Detailed Description

Legitimate patients will receive Standard of Care (SOC) phacoemulsification treatment for cataract and IOL implantation, with or without using LenSx® technology, with followup for 1 month using SOC postsurgical treatment.

Study Timeline

• Study First Submitted: 2015-11-06
• Study First Submitted QC: 2015-11-13
• Study First Posted: 2015-11-16
• Status Verified: 2016-04
• Study Start: 2016-04
• Last Update Submitted: 2016-04-26
• Last Update Posted: 2016-04-27
• Primary Completion: 2016-06
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Agree to undergo phacoemulsification cataract surgery in at least 1 eye;
• Understand and sign an informed consent form;
• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria

• Refuse to sign the informed consent form or have incomplete medical records;
• Contraindications for phacoemulsification treatment per Investigator discretion or listed in LenSx® Operator's Manual;
• Contraindications for anterior capsulotomy, phacofragmentation of the lens using the FLACS;
• Other protocol-specified exclusion criteria may apply.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cataract surgery	LenSx® laser system	Phacoemulsification and artificial IOL implantation with and without LenSx® laser system
Cataract surgery	Phacoemulsification	Phacoemulsification and artificial IOL implantation with and without LenSx® laser system

Primary Outcome Measures

Name	Time	Method
Best Corrected Visual Acuity (BCVA)	Up to Day 30 postoperative
Uncorrected Visual Acuity (UCVA)	Up to Day 30 postoperative
Completion rate of an anterior capsulotomy	Day 0, operative day
Cumulative dissipated energy (CDE)	Day 0, operative day	Cumulative Dissipated Energy (the amount of ultrasound energy entering the eye during the removal of the cataractous lens) will be reported on the Vision System interface and measured in percent-seconds.
Total phaco + IOL time	Day 0, operative day
Aspiration fluid (ml)	Day 0, operative day
Success rate of IOL insertion	Day 0, operative day
Completion rate of cornea incision	Day 0, operative day
Laser procedure time from suction on to off	Day 0, operative day