NCT04286620

Brief Summary

To discuss the prevalence of intra-operative and early post-operative complications of LASIK among individuals who underwent LASIK procedure and review the symptoms, findings, and management options.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2020

Status
unknown

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

February 25, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 27, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

February 27, 2020

Status Verified

February 1, 2020

Enrollment Period

1 year

First QC Date

February 25, 2020

Last Update Submit

February 25, 2020

Conditions

Cornea

Keywords

LASIK complications

Outcome Measures

Primary Outcomes (1)

  • Identification of Intra-operative and early post-operative complications of LASIK

    Assessment of post-LASIK complications

    Baseline

Interventions

LASIKDEVICE

Correcting errors of refraction

Eligibility Criteria

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

Parameters to be included: demographic data, history, symptoms, post-operative uncorrected and best corrected visual acuities, examination findings, and treatment recommendations. Documentation of complications.

You may qualify if:

  • Individuals who are scheduled for LASIK surgery

You may not qualify if:

  • history of previous ocular surgery, and inadequate follow up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Corneal Diseases

Interventions

Keratomileusis, Laser In Situ

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Tarek A Mohamed, Professor

    Ophthalmology department, faculty of medicine, Assiut university hospital

    STUDY DIRECTOR

  • Dalia M El-Sebity, Ass.prof.

    Ophthalmology department, faculty of medicine, Assiut university hospital

    STUDY DIRECTOR

  • Khaled A Mohammed, Ass.prof.

    Ophthalmology department, faculty of medicine, Assiut university hospital

    STUDY DIRECTOR

Central Study Contacts

Abdelrahman M Saad

CONTACT

+201067895256arabasdm.23@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
House officer

Study Record Dates

First Submitted

February 25, 2020

First Posted

February 27, 2020

Study Start

April 1, 2020

Primary Completion

April 1, 2021

Study Completion

June 1, 2021

Last Updated

February 27, 2020

Record last verified: 2020-02