Cataract Surgery in Indian Patients With or Without LenSx® Laser

A Phaco ± LenSx® Procedure Patients Registry in Indian Tertiary Medical Centers

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.

Study Overview

• Status: Withdrawn
• Conditions: Cataracts
• Intervention / Treatment: Device: LenSx® laser system; Procedure: Phacoemulsification

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 Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adults with cataracts who are receiving phacoemulsification (with or without LenSx® procedure) consecutively during the registry period

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cataract surgery; Phacoemulsification and artificial IOL implantation with and without LenSx® laser system	Device: LenSx® laser system; Femtosecond laser system used for cornea incision, capsulotomy and lens fragmentation during cataract surgery; Procedure: Phacoemulsification; Removal of the cataractous lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completion rate of an anterior capsulotomy		Day 0, operative day
Best Corrected Visual Acuity (BCVA)		Up to Day 30 postoperative
Uncorrected Visual Acuity (UCVA)		Up to Day 30 postoperative
Cumulative dissipated energy (CDE)	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.	Day 0, operative day
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

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Head Medical Affairs, MD, Alcon India Pvt. Ltd.

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Anticipated): June 1, 2016
• Study Completion (Anticipated): June 1, 2016

Study Registration Dates

• First Submitted: November 6, 2015
• First Submitted That Met QC Criteria: November 13, 2015
• First Posted (Estimate): November 16, 2015

Study Record Updates

• Last Update Posted (Estimate): April 27, 2016
• Last Update Submitted That Met QC Criteria: April 26, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: CTI742-P001