NCT03292419

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 25, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

April 5, 2022

Status Verified

April 1, 2022

Enrollment Period

3.1 years

First QC Date

September 18, 2017

Last Update Submit

April 3, 2022

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

  • Epithelial thickness maps

    Changes in anterior segment optical coherence tomography epithelial thickness maps.

    12 months

Secondary Outcomes (7)

  • Changes in corrected visual acuity

    12 months

  • Uncorrected distance visual acuity

    12 months

  • Quality of Vision

    12 months

  • Predictability

    12 months

  • Contrast visual acuity

    12 months

  • +2 more secondary outcomes

Study Arms (1)

Topography guided LASI

OTHER
Procedure: Topography-guided LASIK

Interventions

Topography-guided LASIKPROCEDURE

LASIK surgery

Topography guided LASI

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Byers Eye Institute at Stanford

Palo Alto, California, 94303, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Edward E Manche, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
N0ne
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Topography guided
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Ophthalmology

Study Record Dates

First Submitted

September 18, 2017

First Posted

September 25, 2017

Study Start

June 1, 2018

Primary Completion

June 30, 2021

Study Completion

March 31, 2022

Last Updated

April 5, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)