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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Wenzhou Medical University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
STAAR Surgical
Information provided by:
Wenzhou Medical University
ClinicalTrials.gov Identifier:
NCT01088568
First received: March 16, 2010
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

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 Intervention
Myopia
Astigmatism
Procedure: the implantation of toric implantable collamer lens
Procedure: customized laser-assisted in situ keratomileusis

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Wenzhou Medical University:

Primary Outcome Measures:
  • Comparing the efficacy, predictability, stability and safety of TICL versus Q-LASIK [ Time Frame: 1week, 1,3,6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Comparing wavefront aberrometry of TICL vs Q-LASIK Comparing contrast sensitivity of TICL vs Q-LASIK Comparing patient satisfaction of TICL vs Q-LASIK [ Time Frame: 1, 3, 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: November 2007
Estimated Study Completion Date: March 2010
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TICL group Procedure: the implantation of toric implantable collamer lens
perform the implantation of toric implantable collamer lens for both eyes
Other Name: 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 Name: Q-factor customized LASIK

  Eligibility

Ages Eligible for Study:   21 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01088568

Locations
China, Zhejiang
Eye hospital of Wenzhou Medical College
Wenzhou, Zhejiang, China, 325027
Sponsors and Collaborators
Wenzhou Medical University
STAAR Surgical
Investigators
Study Director: Qin Mei Wang Eye hospital of Wenzhou Medical College
  More Information

Publications:
Responsible Party: Qinmei Wang MD, Eye hospital of Wenzhou Medical College
ClinicalTrials.gov Identifier: NCT01088568     History of Changes
Other Study ID Numbers: 20091231
Study First Received: March 16, 2010
Last Updated: March 16, 2010
Health Authority: China: Food and Drug Administration

Keywords provided by Wenzhou Medical University:
Keratomileusis, laser in situ
Phakic Intraocular Lenses
myopia
astigmatism
Implantable Collamer Lens, Toric

Additional relevant MeSH terms:
Astigmatism
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on July 20, 2014