Femtosecond Laser for Cataract Surgery

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02110212
• Other study ID #: OMC-C-3.0
• Status: Terminated
• Phase: Phase 3
• First received: April 8, 2014
• Last updated: June 27, 2014
• Start date: April 2011
• Est. completion date: February 2014

Study information

• Verified date: June 2014
• Source: Abbott Medical Optics
• Contact: n/a
• Is FDA regulated: No
• Health authority: Dominican Republic: Consejo Nacional de Bioetica en Salud
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: February 2014
• Est. primary completion date: December 2011
• 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

• 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract

Intervention

Procedure:
• U/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.

Device:
• FS Laser Surgery
The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery.

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 Dimension	Capsulotomy size will be measured during surgery for both the experimental and control groups.	Day of Surgery	No
Secondary	Cumulative 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