Randomized, Prospective Comparison of the Outcome of TICL and Q Value Customized LASIK for the Correction of Myopia With Astigmatism

Wenzhou Medical University1 site in 1 country30 target enrollmentNovember 2007

ConditionsMyopia Astigmatism

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Myopia
Sponsor: Wenzhou Medical University
Enrollment: 30
Locations: 1
Primary Endpoint: Comparing the efficacy, predictability, stability and safety of TICL versus Q-LASIK
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective is to conduct a contralateral prospective clinical study to compare the safety, efficacy, and quality of vision of the STAAR Surgical Co. Toric Implantable Contact Lens TICL) versus Custom Laser Vision Correction (Q-LASIK) in human eyes for the correction of myopia with astigmatism.

Registry

clinicaltrials.gov

Start Date

November 2007

End Date

March 2010

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Wenzhou Medical University

Eligibility Criteria

Inclusion Criteria

•Age: 21-45 years old
•Documented stable refraction for at least 1 year
•(-3.0 to -8.0D of myopia with -1.0 to -4.0D of astigmatism or SE from -3.5 to -10D
•BSCVA: 20/20 or better
•Pupil diameter: smaller than 7mm under mesopic condition
•Contact lens discontinued 3 weeks and 1 week for hard and soft wearers respectively

Exclusion Criteria

•Evidence of progressive or acute disease
•Evidence of connective tissue disease or clinically significant atopic disease
•ACD less than 2.8mm from endothelium
•ECC less than 2200 cells/mm2
•Narrow angle of anterior chamber
•Residual stromal thickness less than 280 microns

Outcomes

Primary Outcomes

Comparing the efficacy, predictability, stability and safety of TICL versus Q-LASIK

Time Frame: 1week, 1,3,6 months

Secondary Outcomes

Comparing wavefront aberrometry of TICL vs Q-LASIK Comparing contrast sensitivity of TICL vs Q-LASIK Comparing patient satisfaction of TICL vs Q-LASIK(1, 3, 6 months)