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Topography-guided LASIK Surgery

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: NCT03292419
Recruitment Status : Active, not recruiting
First Posted : September 25, 2017
Last Update Posted : July 8, 2020
Sponsor:
Information provided by (Responsible Party):
Edward E. Manche, Stanford University

Brief Summary:
The investigators are analyzing outcomes of topography-guided LASIK surgery in participants with myopia and myopic astigmatism

Condition or disease Intervention/treatment Phase
Myopia Procedure: Topography-guided LASIK Not Applicable

Detailed Description:
The investigators are analyzing outcomes of topography-guided LASIK surgery in participants with myopia and myopic astigmatism. The investigators will be monitoring changes in anterior segment optical coherence tomography epithelial thickness maps. The investigators will compare preoperative maps to postoperative maps at one, three, six and twelve months. In addition, the investigators will measure changes in epithelial maps from postoperative month through twelve months to help understand what is happening to the corneal epithelium to try to explain why UDVA and CDVA improves over time

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Topography guided
Masking: None (Open Label)
Masking Description: N0ne
Primary Purpose: Treatment
Official Title: A Prospective Evaluation of Topography-guided LASIK Surgery
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Topography guided LASI Procedure: Topography-guided LASIK
LASIK surgery




Primary Outcome Measures :
  1. Epithelial thickness maps [ Time Frame: 12 months ]
    Changes in anterior segment optical coherence tomography epithelial thickness maps.


Secondary Outcome Measures :
  1. Changes in corrected visual acuity [ Time Frame: 12 months ]
    Corrected distance visual acuity (CDVA)

  2. Uncorrected distance visual acuity [ Time Frame: 12 months ]
    Uncorrected distance visual acuity (UDVA)

  3. Quality of Vision [ Time Frame: 12 months ]
    Patient reported outcomes questionnaire

  4. Predictability [ Time Frame: 12 months ]
    Percentage of eyes within +/-0.25, 0.50 and 1.00 diopter of the intended correction

  5. Contrast visual acuity [ Time Frame: 12 months ]
    5 and 25% ETDRS contrast acuity

  6. Residual astigmatism levels after surgery [ Time Frame: 12 months ]
    Vector analysis of astigmatic outcomes

  7. Change in refraction over time [ Time Frame: 12 months ]
    Change in spherical equivalent over time



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects age 18 and older with healthy eyes. Nearsightedness between -0.50 diopters and -8.00 diopters.
  • Subjects with up to 3.00 diopters of astigmatism.
  • Subjects with a spherical equivalent of up to -9.00 diopters.

Exclusion Criteria:

  • Subjects under the age of 18.
  • Subjects with excessively thin corneas.
  • Subjects with topographic evidence of keratoconus.
  • Subjects with ectatic eye disorders.
  • Subjects with autoimmune diseases.
  • Subjects who are pregnant or nursing.
  • Subjects with more than 3.00 diopters of astigmatism

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): NCT03292419


Locations
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United States, California
Byers Eye Institute at Stanford
Palo Alto, California, United States, 94303
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Edward E Manche, MD Stanford University
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Responsible Party: Edward E. Manche, Professor of Ophthalmology, Stanford University
ClinicalTrials.gov Identifier: NCT03292419    
Other Study ID Numbers: 43306
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: July 2020
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
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases