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Trial record 1 of 1 for:    Comparison Between TICL and ICL+AK for High Myopic Astigmatism
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Comparison Between TICL and ICL+AK for High Myopic Astigmatism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03202485
Recruitment Status : Completed
First Posted : June 28, 2017
Last Update Posted : June 28, 2017
Sponsor:
Information provided by (Responsible Party):
A-Yong Yu, Wenzhou Medical University

Study Description
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Brief Summary:
To compare the outcomes of a toric Implantable Collamer Lens (ICL) and a spherical Implantable Collamer Lens combined with astigmatic keratotomy (AK) in the correction of high myopic astigmatism.

Condition or disease Intervention/treatment Phase
Astigmatism High Myopia Device: Toric Implantable Collamer Lens Device: ICL + Astigmatic keratotomy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective comparative case series
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison Between Toric and Spherical Implantable Collamer Lens Combined With Astigmatic Keratotomy for High Myopic Astigmatism
Actual Study Start Date : March 3, 2014
Actual Primary Completion Date : March 2, 2015
Actual Study Completion Date : January 1, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Toric Implantable Collamer Lens
Subjects in this group will implant Toric Implantable Collamer Lens for high myopic astigmatism
 Device: Toric Implantable Collamer Lens
uses Toric Implantable Collamer Lens implantation to correct the high myopic astigmatism.
Experimental: ICL+ Astigmatic keratotomy
Subjects in this group will implant Implantable Collamer Lens and combined with astigmatic keratotomy for high myopic astigmatism
 Device: ICL + Astigmatic keratotomy
uses Implantable Collamer Lens implantation combined with Astigmatic keratotomy to correct the high myopic astigmatism


Outcome Measures
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Primary Outcome Measures :
  1. Uncorrected Visual Acuity (UCVA) at distance [ Time Frame: 2 years after surgery ]
    measured at 5 meter

  2. astigmatism [ Time Frame: 2 years after surgery ]
    astigmatism getting from subjective refraction


Secondary Outcome Measures :
  1. Best Corrected Visual Acuity (BCVA) at distance [ Time Frame: 2 years after surgery ]
    subjective refraction

  2. Spherical Equivalent (SE) [ Time Frame: 2 years after surgery ]
    subjective refraction

  3. mean postoperative BCVA/mean preoperative BCVA [ Time Frame: 2 years after surgery ]
    safety index

  4. mean postoperative UCVA/mean preoperative BCVA [ Time Frame: 2 years after surgery ]
    efficacy index


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age ranged from 18 to 40 years,
  • myopia greater than -8.00 diopters (D), and refractive cylinder in the range of 1.50D to 5.50D,
  • for the patients who were planned to undergo AK+ICL implantation, the axial difference between the corneal astigmatism and the manifest refractive astigmatism was less than 10 degree,
  • a stable refractive error during the previous 2 years,
  • anterior chamber depth more than 2.8 mm,
  • endothelial cell density (ECD) more than 2500 cells/mm2, and
  • scotopic pupillary diameter less than 7 mm.

Exclusion Criteria:

  • subjects had significant irregular astigmatism, corneal pathological changes, glaucoma, ocular inflammation, or previous ocular trauma or surgery.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03202485


Sponsors and Collaborators
Wenzhou Medical University
Investigators
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Principal Investigator: AYong Yu, MD.PhD. Wenzhou Medical University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: A-Yong Yu, vice director of refractive surgery department of the eye hospital of WZMU, Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT03202485    
Other Study ID Numbers: TICL compare with ICL+AK
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: June 28, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by A-Yong Yu, Wenzhou Medical University:
astigmatism
high myopia
phakic intraocular lens
astigmatic keratotomy
toric
Additional relevant MeSH terms:
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Myopia
Astigmatism
Refractive Errors
Eye Diseases