Femtosecond Laser for Cataract Surgery

A Prospective, Randomized Study of Cataract Surgery With the Assistance of the OptiMedica Femtosecond Laser System Compared to Standard Surgical Procedure of Continuous Curvilinear Capsulorhexis and Ultrasonic Phacoemulsification

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02110212

Enrollment

Registered

2014-04-10

Start date

2011-04-30

Completion date

2014-02-28

Last updated

2025-02-04

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

Conditions

Cataract

Keywords

Cataract, Surgery, cataract extraction, Optical devices, laser

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.

Interventions

PROCEDUREU/S Surgery and CCC

Subjects will receive the standard of care for U/S cataract surgery and CCC to facilitate removal of the crystalline lens.

DEVICEFS Laser Surgery

The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.

Outcome results

None listed

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