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
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2007-11-30
2010-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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TICL group
the implantation of toric implantable collamer lens
perform the implantation of toric implantable collamer lens for both eyes
LASIK group
customized laser-assisted in situ keratomileusis
perform Q-factor customized laser-assisted in situ keratomileusis for both eyes
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
21 Years
45 Years
ALL
Yes
Sponsors
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Staar Surgical Company
INDUSTRY
Wenzhou Medical University
OTHER
Responsible Party
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Eye hospital of Wenzhou Medical College
Principal Investigators
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Qin Mei Wang
Role: STUDY_DIRECTOR
Eye hospital of Wenzhou Medical College
Locations
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Eye hospital of Wenzhou Medical College
Wenzhou, Zhejiang, China
Countries
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References
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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.
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.
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.
Other Identifiers
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20091231
Identifier Type: -
Identifier Source: org_study_id
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