Randomized, Prospective Comparison of the Outcome of Toric Implantable Contact Lens (TICL) and Q-LASIK for the Correction of Myopia With Astigmatism

Not Applicable

• Conditions: Myopia; Astigmatism
• Interventions: Procedure: the implantation of toric implantable collamer lens; Procedure: customized laser-assisted in situ keratomileusis

• Registration Number: NCT01088568
• Lead Sponsor: Wenzhou Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Primary Completion: 2008-12
• Status Verified: 2009-10
• Study Completion: 2010-03
• Study First Submitted: 2010-03-16
• Study First Submitted QC: 2010-03-16
• Last Update Submitted: 2010-03-16
• Study First Posted: 2010-03-17
• Last Update Posted: 2010-03-17

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TICL group	the implantation of toric implantable collamer lens	-
LASIK group	customized laser-assisted in situ keratomileusis	-

Primary Outcome Measures

Name	Time	Method
Comparing the efficacy, predictability, stability and safety of TICL versus Q-LASIK	1week, 1,3,6 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Eye hospital of Wenzhou Medical College; 🇨🇳 Wenzhou, Zhejiang, China