Assessment of the Preoperative Risk Factors for the Devel... | NCT06806306

Studies
Assessment of the Preoperative Risk Factors for the Development of Post-LASIK Ectasia

NCT06806306

Sponsor

Al-Azhar University

Status

Completed

Last Update Posted

Feb 4, 2025Actual

Enrollment

13Actual

Phase

Not provided

Conditions

Lasik Eye Surgery

Interventions

LASIK

Countries

Not provided

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

Jan 2025

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

Oct 1, 2013Actual

Primary Completion Date

Aug 1, 2024Actual

Completion Date

Aug 25, 2024Actual

First Submitted Date

Jan 29, 2025

First Submission Date that Met QC Criteria

Jan 29, 2025

First Posted Date

Feb 4, 2025Actual

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

Jan 29, 2025

Last Update Posted Date

Feb 4, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

: Laser-assisted in situ keratomileusis (LASIK) is one of the most widely performed refractive surgeries, offering effective and long-lasting correction for visual refractive errors. While LASIK has a high success rate and is generally safe, post-LASIK ectasia remains a rare but serious complication that compromises visual outcomes. Several risk factors for post-LASIK ectasia have been identified. The aim of the present study is to determine the preoperative risk factors for the development of post-LASIK ectasia.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

13Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LASIK	Procedure	Laser-assisted in situ keratomileusis is one of the most widely performed refractive surgeries for correcting myopia, hyperopia, and astigmatism

Measure	Description	Time Frame
Randleman ectasia score		At the baseline

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of corneal ectasia was made by progressive central or inferior corneal steepening, increased myopia and/or astigmatism, and decreased visual acuity

Exclusion Criteria:

Subjects who had glaucoma diagnosis, other corneal surgeries (other than LASIK), and central corneal opacity

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

LASIK patients

Sampling Method

Non-Probability Sample

Intervention Browse Module

MeSH Terms

ID	Term
D020731	Keratomileusis, Laser In Situ

Ancestor Terms

ID	Term
D048988	Corneal Surgery, Laser
D053685	Laser Therapy
D013812	Therapeutics
D055011	Ablation Techniques

Browse Leaves

Not provided

Browse Branches

Not provided