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

Wenzhou Medical University

Status: Unknown

Conditions: Myopia; Astigmatism

Treatments: Procedure: customized laser-assisted in situ keratomileusis; Procedure: the implantation of toric implantable collamer lens

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01088568

20091231

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 21 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

TICL group

Experimental group

Treatment:

Procedure: the implantation of toric implantable collamer lens

LASIK group

Active Comparator group

Treatment:

Procedure: customized laser-assisted in situ keratomileusis