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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01088568
• Other study ID #: 20091231
• Status: Unknown status
• Phase: N/A
• First received: March 16, 2010
• Last updated: March 16, 2010
• Start date: November 2007
• Est. completion date: March 2010

Study information

• Verified date: October 2009
• Source: Wenzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 30
• Est. completion date: March 2010
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Astigmatism
• Myopia

Intervention

Procedure:
• the implantation of toric implantable collamer lens
perform the implantation of toric implantable collamer lens for both eyes
• customized laser-assisted in situ keratomileusis
perform Q-factor customized laser-assisted in situ keratomileusis for both eyes

Locations

Country	Name	City	State
China	Eye hospital of Wenzhou Medical College	Wenzhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Wenzhou Medical University	STAAR Surgical

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparing the efficacy, predictability, stability and safety of TICL versus Q-LASIK		1week, 1,3,6 months
Secondary	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