Topography-guided LASIK Surgery | NCT03292419

Studies
Topography-guided LASIK Surgery

NCT03292419

Sponsor

Stanford University

Status

Completed

Last Update Posted

Apr 5, 2022Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Myopia

Interventions

Topography-guided LASIK

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2018Actual

Primary Completion Date

Jun 30, 2021Actual

Completion Date

Mar 31, 2022Actual

First Submitted Date

Sep 18, 2017

First Submission Date that Met QC Criteria

Sep 20, 2017

First Posted Date

Sep 25, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 3, 2022

Last Update Posted Date

Apr 5, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Topography guided LASI	Other		Procedure: Topography-guided LASIK

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Topography-guided LASIK	Procedure	LASIK surgery	Topography guided LASI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Epithelial thickness maps	Changes in anterior segment optical coherence tomography epithelial thickness maps.	12 months

Secondary Outcomes

Measure	Description	Time Frame
Changes in corrected visual acuity	Corrected distance visual acuity (CDVA)	12 months
Uncorrected distance visual acuity	Uncorrected distance visual acuity (UDVA)

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

59 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Edward E Manche, MD	Stanford University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Byers Eye Institute at Stanford		Palo Alto	California	94303	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009216	Myopia

Ancestor Terms

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided