Study Stopped
Management Decision
Cataract Surgery in Indian Patients With or Without LenSx® Laser
A Phaco ± LenSx® Procedure Patients Registry in Indian Tertiary Medical Centers
1 other identifier
observational
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2016
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 6, 2015
CompletedFirst Posted
Study publicly available on registry
November 16, 2015
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedApril 27, 2016
April 1, 2016
2 months
November 6, 2015
April 26, 2016
Conditions
Outcome Measures
Primary Outcomes (9)
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
Study Arms (1)
Cataract surgery
Phacoemulsification and artificial IOL implantation with and without LenSx® laser system
Interventions
Femtosecond laser system used for cornea incision, capsulotomy and lens fragmentation during cataract surgery
Eligibility Criteria
Adults with cataracts who are receiving phacoemulsification (with or without LenSx® procedure) consecutively during the registry period
You may qualify if:
- Agree to undergo phacoemulsification cataract surgery in at least 1 eye;
- Understand and sign an informed consent form;
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Head Medical Affairs, MD
Alcon India Pvt. Ltd.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 6, 2015
First Posted
November 16, 2015
Study Start
April 1, 2016
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
April 27, 2016
Record last verified: 2016-04