Topography-guided LASIK Surgery

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Procedure: Topography-guided LASIK

• Registration Number: NCT03292419
• Lead Sponsor: Stanford University

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2017-09-18
• Study First Submitted QC: 2017-09-20
• Study First Posted: 2017-09-25
• Study Start: 2018-06-01
• Primary Completion: 2021-06-30
• Study Completion: 2022-03-31
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-03
• Last Update Posted: 2022-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Topography guided LASI	Topography-guided LASIK	-

Primary Outcome Measures

Name	Time	Method
Epithelial thickness maps	12 months	Changes in anterior segment optical coherence tomography epithelial thickness maps.

Secondary Outcome Measures

Name	Time	Method
Contrast visual acuity	12 months	5 and 25% ETDRS contrast acuity
Change in refraction over time	12 months	Change in spherical equivalent over time
Predictability	12 months	Percentage of eyes within +/-0.25, 0.50 and 1.00 diopter of the intended correction
Changes in corrected visual acuity	12 months	Corrected distance visual acuity (CDVA)
Uncorrected distance visual acuity	12 months	Uncorrected distance visual acuity (UDVA)
Quality of Vision	12 months	Patient reported outcomes questionnaire
Residual astigmatism levels after surgery	12 months	Vector analysis of astigmatic outcomes

Trial Locations

Locations (1)

Byers Eye Institute at Stanford; 🇺🇸 Palo Alto, California, United States