Topography-guided LASIK Surgery

Myopia Clinical Trial

Official title:

A Prospective Evaluation of Topography-guided LASIK Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03292419
• Other study ID #: 43306
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: March 31, 2022

Study information

• Verified date: April 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 31, 2022
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Myopia

Intervention

Procedure:
• Topography-guided LASIK
LASIK surgery

Locations

Country	Name	City	State
United States	Byers Eye Institute at Stanford	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Epithelial thickness maps	Changes in anterior segment optical coherence tomography epithelial thickness maps.	12 months
Secondary	Changes in corrected visual acuity	Corrected distance visual acuity (CDVA)	12 months
Secondary	Uncorrected distance visual acuity	Uncorrected distance visual acuity (UDVA)	12 months
Secondary	Quality of Vision	Patient reported outcomes questionnaire	12 months
Secondary	Predictability	Percentage of eyes within +/-0.25, 0.50 and 1.00 diopter of the intended correction	12 months
Secondary	Contrast visual acuity	5 and 25% ETDRS contrast acuity	12 months
Secondary	Residual astigmatism levels after surgery	Vector analysis of astigmatic outcomes	12 months
Secondary	Change in refraction over time	Change in spherical equivalent over time	12 months