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

Study Overview
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Brief Summary
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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.

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

Conditions
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Myopia, Astigmatism

Intervention / Treatment
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* Procedure: the implantation of toric implantable collamer lens
* Procedure: customized laser-assisted in situ keratomileusis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TICL group<br> | Procedure: the implantation of toric implantable collamer lens<br>* perform the implantation of toric implantable collamer lens for both eyes<br>* Other names: TICL;|
| Active Comparator: LASIK group<br> | Procedure: customized laser-assisted in situ keratomileusis<br>* perform Q-factor customized laser-assisted in situ keratomileusis for both eyes<br>* Other names: Q-factor customized LASIK;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparing the efficacy, predictability, stability and safety of TICL versus Q-LASIK |  | 1week, 1,3,6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Keratomileusis, laser in situ, Phakic Intraocular Lenses, myopia, astigmatism, Implantable Collamer Lens, Toric