This trial is active, not recruiting.

Conditions myopia, astigmatism
Treatments the implantation of toric implantable collamer lens, customized laser-assisted in situ keratomileusis
Sponsor Wenzhou Medical University
Collaborator STAAR Surgical
Start date November 2007
End date December 2008
Trial size 30 participants
Trial identifier NCT01088568, 20091231


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
the implantation of toric implantable collamer lens TICL
perform the implantation of toric implantable collamer lens for both eyes
(Active Comparator)
customized laser-assisted in situ keratomileusis Q-factor customized LASIK
perform Q-factor customized laser-assisted in situ keratomileusis for both eyes

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
time frame: 1, 3, 6 months

Eligibility Criteria

Male or female participants from 21 years up to 45 years old.

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

Additional Information

Official title Randomized, Prospective Comparison of the Outcome of TICL and Q Value Customized LASIK for the Correction of Myopia With Astigmatism
Trial information was received from ClinicalTrials.gov and was last updated in March 2010.
Information provided to ClinicalTrials.gov by Wenzhou Medical University.