Topography-guided LASIK Surgery

NCT ID: NCT03292419

Last Updated: 2022-04-05

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2022-03-31

Brief Summary

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

Detailed Description

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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

Conditions

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Myopia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Topography guided
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

N0ne

Study Groups

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Topography guided LASI

Group Type OTHER

Topography-guided LASIK

Intervention Type PROCEDURE

LASIK surgery

Interventions

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Topography-guided LASIK

LASIK surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Edward E. Manche

Professor of Ophthalmology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Edward E Manche, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Byers Eye Institute at Stanford

Palo Alto, California, United States

Site Status

Countries

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United States

Other Identifiers

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43306

Identifier Type: -

Identifier Source: org_study_id

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