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Cataract Surgery in Indian Patients With or Without LenSx® Laser

Sponsor
Alcon Research (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT02605408
Collaborator
(none)
0
Enrollment
2
Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
0 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Phaco ± LenSx® Procedure Patients Registry in Indian Tertiary Medical Centers
Study Start Date :
Apr 1, 2016
Anticipated Primary Completion Date :
Jun 1, 2016
Anticipated Study Completion Date :
Jun 1, 2016

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Completion rate of an anterior capsulotomy [Day 0, operative day]

  2. Best Corrected Visual Acuity (BCVA) [Up to Day 30 postoperative]

  3. Uncorrected Visual Acuity (UCVA) [Up to Day 30 postoperative]

  4. 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.

  5. Total phaco + IOL time [Day 0, operative day]

  6. Aspiration fluid (ml) [Day 0, operative day]

  7. Success rate of IOL insertion [Day 0, operative day]

  8. Completion rate of cornea incision [Day 0, operative day]

  9. Laser procedure time from suction on to off [Day 0, operative day]

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Alcon Research

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alcon Research
ClinicalTrials.gov Identifier:
NCT02605408
Other Study ID Numbers:
  • CTI742-P001
First Posted:
Nov 16, 2015
Last Update Posted:
Apr 27, 2016
Last Verified:
Apr 1, 2016
Additional relevant MeSH terms:
Cataract

Study Results

No Results Posted as of Apr 27, 2016