Femtosecond Laser for Cataract Surgery

Phase 3

Terminated

• Conditions: Cataract

• Registration Number: NCT02110212
• Lead Sponsor: Abbott Medical Optics

Brief Summary

The objective of this study is to evaluate the safety and efficacy the OptiMedica Femtosecond Laser System, also known as the Catalys™ Precision Laser System, to perform two surgical maneuvers used in the treatment of subjects with cataracts. Efficacy will be evaluated by comparisons to the standard surgical procedure of continuous curvilinear capsulorhexis (CCC) and ultrasonic phacoemulsification.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Primary Completion: 2011-12
• Study Completion: 2014-02
• Study First Submitted: 2014-04-08
• Study First Submitted QC: 2014-04-08
• Study First Posted: 2014-04-10
• Disposition First Submitted: 2014-05-15
• Disposition First Submitted QC: 2014-06-27
• Disposition First Posted: 2014-07-03
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• Able and willing to comply with the treatment/follow-up schedule and requirements
• Able to understand and provide written Informed Consent
• ETDRS visual acuity equal to or worse than 20/32 (best corrected)
• Age between 50 and 80 years old
• Pupil dilates to at least 6 mm
• Subject able to fixate
• Grade 1-4 nuclear sclerotic cataract (LOCS III)
• Axial length between 22 and 26 mm

Exclusion Criteria

• Pregnant, intending to become pregnant during course of the study, less than 3 months postpartum or less than 6 weeks after completion of breastfeeding
• Participation in a study of another device or drug within 3 months prior to study enrollment or during this study, and as per the Investigator's careful discretion, as long as not contradictory to any of the above criteria
• Any condition which, in the Investigator's opinion, would make it unsafe (for the subject or for the study personnel) to treat the subject as part of this research study or for which cataract surgery is contraindicated
• Anterior chamber depth (anterior corneal surface to anterior capsule margin) less than 2.5 mm via IOL Master (Zeiss).
• History of prior ocular surgery
• History of ocular trauma
• Co-existing ocular disease affecting vision
• History or current use of alpha-1 antagonist medication (e.g., Flomax)
• Known sensitivity to planned concomitant medications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Capsulotomy Dimension	Day of Surgery	Capsulotomy size will be measured during surgery for both the experimental and control groups.

Secondary Outcome Measures

Name	Time	Method
Cumulative Dissipated Energy (CDE)	Day of Surgery	CDE (the amount of ultrasound energy delivered during phacoemulsification of the crystalline lens) used will be measured during surgery.