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

Primary Purpose

Myopia, Astigmatism

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
the implantation of toric implantable collamer lens
customized laser-assisted in situ keratomileusis
Sponsored by
Wenzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia focused on measuring Keratomileusis, laser in situ, Phakic Intraocular Lenses, myopia, astigmatism, Implantable Collamer Lens, Toric

Eligibility Criteria

21 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Eye hospital of Wenzhou Medical College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TICL group

LASIK group

Arm Description

Outcomes

Primary Outcome Measures

Comparing the efficacy, predictability, stability and safety of TICL versus Q-LASIK

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

Full Information

First Posted
March 16, 2010
Last Updated
March 16, 2010
Sponsor
Wenzhou Medical University
Collaborators
Staar Surgical Company
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1. Study Identification

Unique Protocol Identification Number
NCT01088568
Brief Title
Randomized, Prospective Comparison of the Outcome of Toric Implantable Contact Lens (TICL) and Q-LASIK for the Correction of Myopia With Astigmatism
Official Title
Randomized, Prospective Comparison of the Outcome of TICL and Q Value Customized LASIK for the Correction of Myopia With Astigmatism
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Unknown status
Study Start Date
November 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
March 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Wenzhou Medical University
Collaborators
Staar Surgical Company

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Astigmatism
Keywords
Keratomileusis, laser in situ, Phakic Intraocular Lenses, myopia, astigmatism, Implantable Collamer Lens, Toric

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TICL group
Arm Type
Experimental
Arm Title
LASIK group
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
the implantation of toric implantable collamer lens
Other Intervention Name(s)
TICL
Intervention Description
perform the implantation of toric implantable collamer lens for both eyes
Intervention Type
Procedure
Intervention Name(s)
customized laser-assisted in situ keratomileusis
Other Intervention Name(s)
Q-factor customized LASIK
Intervention Description
perform Q-factor customized laser-assisted in situ keratomileusis for both eyes
Primary Outcome Measure Information:
Title
Comparing the efficacy, predictability, stability and safety of TICL versus Q-LASIK
Time Frame
1week, 1,3,6 months
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qin Mei Wang
Organizational Affiliation
Eye hospital of Wenzhou Medical College
Official's Role
Study Director
Facility Information:
Facility Name
Eye hospital of Wenzhou Medical College
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325027
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
17598571
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. doi: 10.3928/1081-597X-20070601-02.
Results Reference
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PubMed Identifier
17172886
Citation
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.
Results Reference
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PubMed Identifier
12792475
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. doi: 10.1097/00003226-200305000-00009.
Results Reference
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Learn more about this trial

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

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