Cataract Surgery in Indian Patients With or Without LenSx® Laser

Cataracts Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02605408
• Other study ID #: CTI742-P001
• Status: Withdrawn
• Phase: N/A
• First received: November 6, 2015
• Last updated: April 26, 2016
• Start date: April 2016
• Est. completion date: June 2016

Study information

• Verified date: April 2016
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cataract
• Cataracts

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion rate of an anterior capsulotomy		Day 0, operative day	No
Primary	Best Corrected Visual Acuity (BCVA)		Up to Day 30 postoperative	No
Primary	Uncorrected Visual Acuity (UCVA)		Up to Day 30 postoperative	No
Primary	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	No
Primary	Total phaco + IOL time		Day 0, operative day	Yes
Primary	Aspiration fluid (ml)		Day 0, operative day	No
Primary	Success rate of IOL insertion		Day 0, operative day	No
Primary	Completion rate of cornea incision		Day 0, operative day	No
Primary	Laser procedure time from suction on to off		Day 0, operative day	No