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

NCT ID: NCT01088568

Last Updated: 2010-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2010-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Myopia Astigmatism

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TICL group

Group Type EXPERIMENTAL

the implantation of toric implantable collamer lens

Intervention Type PROCEDURE

perform the implantation of toric implantable collamer lens for both eyes

LASIK group

Group Type ACTIVE_COMPARATOR

customized laser-assisted in situ keratomileusis

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

the implantation of toric implantable collamer lens

perform the implantation of toric implantable collamer lens for both eyes

Intervention Type PROCEDURE

customized laser-assisted in situ keratomileusis

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

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

TICL Q-factor customized LASIK

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

21 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Staar Surgical Company

INDUSTRY

Sponsor Role collaborator

Wenzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Eye hospital of Wenzhou Medical College

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Qin Mei Wang

Role: STUDY_DIRECTOR

Eye hospital of Wenzhou Medical College

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Eye hospital of Wenzhou Medical College

Wenzhou, Zhejiang, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

Sanders DR. Matched population comparison of the Visian Implantable Collamer Lens and standard LASIK for myopia of -3.00 to -7.88 diopters. J Refract Surg. 2007 Jun;23(6):537-53. doi: 10.3928/1081-597X-20070601-02.

Reference Type BACKGROUND
PMID: 17598571 (View on PubMed)

Sanders D, Vukich JA. Comparison of implantable collamer lens (ICL) and laser-assisted in situ keratomileusis (LASIK) for low myopia. Cornea. 2006 Dec;25(10):1139-46. doi: 10.1097/ICO.0b013e31802cbf3c.

Reference Type BACKGROUND
PMID: 17172886 (View on PubMed)

Sanders DR, Vukich JA. Comparison of implantable contact lens and laser assisted in situ keratomileusis for moderate to high myopia. Cornea. 2003 May;22(4):324-31. doi: 10.1097/00003226-200305000-00009.

Reference Type BACKGROUND
PMID: 12792475 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20091231

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Surgical Correction of Astigmatism
NCT01680354 WITHDRAWN NA