A Study of Cataract Surgery With the Femtosecond Laser

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00922571
• Other study ID #: OMC-C-1.1
• Status: Terminated
• Phase: N/A
• First received: June 16, 2009
• Last updated: August 1, 2016
• Start date: June 2009
• Est. completion date: May 2014

Study information

• Verified date: August 2016
• Source: Abbott Medical Optics
• Contact: n/a
• Is FDA regulated: No
• Health authority: Dominican Republic: Secretaría del Estado de Salud Pública y Asistencia Social (SESPAS)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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.)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cataract

Intervention

Procedure:
• FS Laser Surgery
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.

Device:
• FS 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.

Locations

Country	Name	City	State
Dominican Republic	Laser Center	Santo Domingo

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Optics

Country where clinical trial is conducted

Dominican Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Capsulotomy Size	Capsulotomy size will be measured during surgery.	Day of Surgery	No
Secondary	Cumulated Dissipated Energy (CDE)	CDE (the amount of ultrasound energy delivered during phacoemulsification of the crystalline lens) used will be measured during surgery.	Day of surgery	No