Cataract Surgery in Indian Patients With or Without LenSx® Laser

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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02605408

Enrollment

Registered

2015-11-16

Start date

2016-04-30

Completion date

2016-06-30

Last updated

2016-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataracts

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.

Interventions

DEVICELenSx® laser system

Femtosecond laser system used for cornea incision, capsulotomy and lens fragmentation during cataract surgery

PROCEDUREPhacoemulsification

Removal of the cataractous lens

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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)	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	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026