Skip to content

A Study of Cataract Surgery With the Femtosecond Laser

A Study of Cataract Surgery With the Assistance of the Femtosecond Laser

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00922571
Enrollment
100
Registered
2009-06-17
Start date
2009-06-30
Completion date
2014-05-31
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, Femtosecond laser

Brief summary

The purpose of this study is to evaluate the feasibility of using the Femtosecond Laser System to perform surgical maneuvers during cataract extraction surgery.

Interventions

The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery. The intervention consists of the both surgery and the use of the device.

DEVICEFS Laser System

The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery. The intervention consists of the both surgery and the use of the device.

Sponsors

Abbott Medical Optics
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Able and willing to comply with the treatment/follow-up schedule and requirements * Able to understand and provide written Informed Consent * 3\. ETDRS visual acuity equal to or worse than 20/30 (best corrected) * Patient age between 50 and 80 years old * Pupil dilates to at least 8 mm * Patient able to fixate * 1-3+ nuclear sclerotic cataract(This criterion does not apply to subjects who will receive post-IOL corneal relaxing incisions) * Axial length between 22 and 26 mm

Exclusion criteria

* Pregnant, intending to become pregnant during course of study, less than 3 months postpartum or less than 6 weeks after completion of breast feeding * 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 * Anterior chamber depth less than 2.5 mm via Optical Coherence Tomography (Visante, Zeiss) or IOL Master (Zeiss) measurements * History of prior ocular surgery * History of ocular trauma * Co-existing ocular disease affecting vision * Astigmatism greater than five diopters (D.)

Design outcomes

Primary

MeasureTime frameDescription
Capsulotomy SizeDay of SurgeryCapsulotomy size will be measured during surgery.

Secondary

MeasureTime frameDescription
Cumulated Dissipated Energy (CDE)Day of surgeryCDE (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