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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01088568

Enrollment

Registered

2010-03-17

Start date

2007-11-30

Completion date

2010-03-31

Last updated

2010-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Astigmatism, Myopia

Keywords

Keratomileusis, laser in situ, Phakic Intraocular Lenses, myopia, astigmatism, Implantable Collamer Lens, Toric

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.

Interventions

PROCEDUREthe implantation of toric implantable collamer lens

perform the implantation of toric implantable collamer lens for both eyes

PROCEDUREcustomized laser-assisted in situ keratomileusis

perform Q-factor customized laser-assisted in situ keratomileusis for both eyes

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026