NCT07647146

Brief Summary

This study evaluates corneal epithelial thickness using anterior segment optical coherence tomography (AS-OCT) in patients with refractive errors. It aims to assess the relationship between epithelial thickness patterns and different types of refractive errors.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
360

participants targeted

Target at P75+ for all trials

Timeline
10mo left

Started Jul 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 15, 2026

Completed
16 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

June 15, 2026

Status Verified

June 1, 2026

Enrollment Period

10 months

First QC Date

June 9, 2026

Last Update Submit

June 9, 2026

Conditions

Keywords

Corneal epithelial thickness, AS-OCT, anterior segment optical coherence tomography, refractive errors, myopia, hyperopia, astigmatism, cornea

Outcome Measures

Primary Outcomes (1)

  • Measurement of corneal epithelial thickness using AS-OCT

    Corneal epithelial thickness will be measured using anterior segment optical coherence tomography (AS-OCT). Measurements will include central and regional epithelial thickness values in microns in patients with different refractive errors.

    At baseline during a single study visit when participants undergo AS-OCT examination.

Secondary Outcomes (4)

  • Comparison of epithelial thickness between myopic and hyperopic eyes

    At baseline (single visit)

  • Comparison of epithelial thickness in eyes with and without astigmatism

    At baseline (single visit)

  • Corneal epithelial thickness asymmetry across corneal regions and inter-eye comparison

    At baseline (single visit)

  • Comparison of epithelial thickness in low and high refractive errors

    At baseline (single visit)

Study Arms (1)

All Participants

All participants diagnosed with refractive errors (myopia, hyperopia, astigmatism) and emmetropia will be included in the study. All subjects will undergo anterior segment optical coherence tomography (AS-OCT) for corneal epithelial thickness mapping. Participants will then be analyzed according to their refractive status.

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult participants (≥18 years) with refractive errors, including myopia, hyperopia, and astigmatism, as well as emmetropic subjects, recruited from the Ophthalmology Department and undergoing anterior segment optical coherence tomography (AS-OCT) examination.

You may qualify if:

  • Age ≥ 18 years-
  • Patients diagnosed with myopia or hyperopia by refraction
  • Clear cornea with no evidence of corneal pathology
  • Ability to undergo reliable anterior segment imaging

You may not qualify if:

  • Inability to fixate or follow instructions
  • Family history of keratoconus
  • Glaucoma,Cataract
  • Previous ocular surgery including refractive surgery
  • Keratoconus or suspected corneal ectasia
  • Corneal opacities or scars
  • Contact lens wear within the last two weeks
  • Ocular trauma
  • systemic disease affecting the cornea ( Such as diabetes)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University Hospital

Sohag, Sohag Governorate, 82524, Egypt

Location

MeSH Terms

Conditions

MyopiaHyperopiaAstigmatismRefractive ErrorsCorneal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Engy Mohamed Mostafa, Professor

    Department of Ophthalmology, Faculty of Medicine, Sohag University

    PRINCIPAL INVESTIGATOR
  • Amin Abu-Ali Hassan, Assistant Professor

    Department of Ophthalmology, Faculty of Medicine, Sohag University

    STUDY DIRECTOR
  • Yasmeen Gamal Abd-El latif, Lecturer

    Department of Ophthalmology, Faculty of Medicine, Sohag University

    STUDY DIRECTOR

Central Study Contacts

Merna romany loza, MBBCh, Ophthalmology Resident

CONTACT

Engy Mohamed Mostafa, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Sub-investigator(resident)

Study Record Dates

First Submitted

June 9, 2026

First Posted

June 15, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

June 15, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared.

Locations