NCT06806306

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2013

Longer than P75 for all trials

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

Study Start

First participant enrolled

October 1, 2013

Completed
10.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 4, 2025

Completed
Last Updated

February 4, 2025

Status Verified

January 1, 2025

Enrollment Period

10.8 years

First QC Date

January 29, 2025

Last Update Submit

January 29, 2025

Conditions

Lasik Eye Surgery

Outcome Measures

Primary Outcomes (1)

  • Randleman ectasia score

    At the baseline

Interventions

LASIKPROCEDURE

Laser-assisted in situ keratomileusis is one of the most widely performed refractive surgeries for correcting myopia, hyperopia, and astigmatism

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

LASIK patients

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Keratomileusis, Laser In Situ

Intervention Hierarchy (Ancestors)

Corneal Surgery, LaserLaser TherapyTherapeuticsAblation TechniquesSurgical Procedures, OperativeKeratectomyRefractive Surgical ProceduresOphthalmologic Surgical Procedures

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinicipal Investigator

Study Record Dates

First Submitted

January 29, 2025

First Posted

February 4, 2025

Study Start

October 1, 2013

Primary Completion

August 1, 2024

Study Completion

August 25, 2024

Last Updated

February 4, 2025

Record last verified: 2025-01