Randomized, Prospective Comparison of the Outcome of Toric Implantable Contact Lens (TICL) and Q-LASIK for the Correction of Myopia With Astigmatism
This trial is active, not recruiting.
|Treatments||the implantation of toric implantable collamer lens, customized laser-assisted in situ keratomileusis|
|Sponsor||Wenzhou Medical University|
|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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Comparing the efficacy, predictability, stability and safety of TICL versus Q-LASIK
time frame: 1week, 1,3,6 months
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
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
|Official title||Randomized, Prospective Comparison of the Outcome of TICL and Q Value Customized LASIK for the Correction of Myopia With Astigmatism|
Call for more information