Study of the Femtosecond Laser System as Compared to Continuous Curvilinear Capsulorhexis 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: Completed

Administrative data

• NCT number: NCT01069172
• Other study ID #: OMC-C-2.0
• Status: Completed
• Phase: Phase 3
• First received: February 13, 2010
• Last updated: August 25, 2014
• Start date: February 2010
• Est. completion date: August 2010

Study information

• Verified date: August 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 purpose of this study is to evaluate the safety and efficacy of the OptiMedica Femtosecond Laser System to perform surgical maneuvers used in the treatment of subjects with cataracts. The safety and efficacy will be compared to the standard surgical procedure of continuous curvilinear capsulorhexis (CCC) and ultrasonic phacoemulsification.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2010
• Est. primary completion date: July 2010
• 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 (Early Treatment of Diabetic Retinopathy Study) visual acuity equal to or worse than 20/32 (best corrected)

• Age between 50 and 80 years old

• Pupil dilates to at least 7 mm

• Subject able to fixate

• Grade 1-4 nuclear sclerotic cataract (Lens Opacities Classification System - 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

Device:
• FS Laser Surgery
The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery to perform capsulotomy, lens segmentation, and lens softening, which are all part of cataract surgery when this femtosecond laser is used.

Procedure:
• CCC Surgery
Subjects will receive the standard of care for CCC and U/S cataract surgery to facilitate removal of the crystalline lens. CCC is a procedure that is part of 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	Deviation From Intended Capsulotomy Diameter	Capsulotomy diameter 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. CDE is a unit used for the Alcon Infinity System (the U/S phacoemulsification used in this study). It is not expressed in standard units such as watts or Joules. CDE, which accounts for the power and time of two ultrasound delivery modes (longitudinal and torsional), is calculated as follows: CDE = (Phaco time x average phaco power) + (torsional time x average torsional aptitude x 0.4); 0.4 is a factor representing the approximate reduction of heat dissipated at the incision as compared to conventional phacoemulsification.	Day of Surgery	No