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

• Sponsor: Wenzhou Medical University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01088568
• Collaborator: Staar Surgical Company (Industry)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 28
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myopia; Astigmatism	Procedure: the implantation of toric implantable collamer lens; Procedure: customized laser-assisted in situ keratomileusis	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomized, Prospective Comparison of the Outcome of TICL and Q Value Customized LASIK for the Correction of Myopia With Astigmatism
• Study Start Date: Nov 1, 2007
• Actual Primary Completion Date: Dec 1, 2008
• Anticipated Study Completion Date: Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TICL group	Procedure: the implantation of toric implantable collamer lens; perform the implantation of toric implantable collamer lens for both eyes; Other Names: TICL
Active Comparator: LASIK group	Procedure: customized laser-assisted in situ keratomileusis; perform Q-factor customized laser-assisted in situ keratomileusis for both eyes; Other Names: Q-factor customized LASIK

Outcome Measures

Primary Outcome Measures

1. Comparing the efficacy, predictability, stability and safety of TICL versus Q-LASIK [1week, 1,3,6 months]

Secondary Outcome Measures

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eye hospital of Wenzhou Medical College	Wenzhou	Zhejiang	China	325027

Sponsors and Collaborators

• Wenzhou Medical University
• Staar Surgical Company

Investigators

• Study Director: Qin Mei Wang, Eye hospital of Wenzhou Medical College

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.

• ClinicalTrials.gov Identifier: NCT01088568
• Other Study ID Numbers: 20091231
• First Posted: Mar 17, 2010
• Last Update Posted: Mar 17, 2010
• Last Verified: Oct 1, 2009

• Keywords provided by , ,: Keratomileusis, laser in situ; Phakic Intraocular Lenses; myopia; astigmatism; Implantable Collamer Lens, Toric
• Additional relevant MeSH terms: Myopia; Astigmatism

Study Results

No Results Posted as of Mar 17, 2010