- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07647146
Corneal Epithelial Thickness Mapping by Anterior Segment Optical Coherence Tomography in Patients With Refractive Errors
June 9, 2026 updated by: Merna Romany Kamel, Sohag University
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.
Study Overview
Status
Not yet recruiting
Conditions
Detailed Description
Refractive errors are among the most common ocular conditions affecting visual acuity.
Corneal epithelial thickness has been suggested to play a role in the optical properties of the eye and may vary among different refractive states.
This observational study aims to evaluate corneal epithelial thickness mapping using anterior segment optical coherence tomography (AS-OCT) in patients with refractive errors.
Patients will be assessed and categorized according to their refractive status, and epithelial thickness measurements will be obtained and analyzed.
The study seeks to investigate potential correlations between epithelial thickness distribution and different types of refractive errors to enhance understanding of corneal biomechanics in refractive conditions.
Study Type
Observational
Enrollment (Estimated)
360
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Merna romany loza, MBBCh, Ophthalmology Resident
- Phone Number: 01275800331
- Email: mernaromany54@yahoo.com
Study Contact Backup
- Name: Engy Mohamed Mostafa, Professor
- Phone Number: 01005643587
- Email: Engymostafa@yahoo.com
Study Locations
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Sohag Governorate
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Sohag, Sohag Governorate, Egypt, 82524
- Sohag university hospital
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Contact:
- Engy Mohamed Mostafa, Professor
- Phone Number: 01005643587
- Email: Engymostafa@yahoo.com
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Contact:
- Amin Abu-Ali Hassan, Assistant Professor
- Phone Number: 01015437008
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Principal Investigator:
- Engy Mohamed Mostafa, Professor
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Sub-Investigator:
- Amin Abu-Ali Hassan, Assistant Professor
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Sub-Investigator:
- Yasmeen Gamal Abd-El latif, Lecturer
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Sub-Investigator:
- Merna Romany Loza, MBBCh, Ophthalmology Resident
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-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.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Measurement of corneal epithelial thickness using AS-OCT
Time Frame: At baseline during a single study visit when participants undergo AS-OCT examination.
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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.
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At baseline during a single study visit when participants undergo AS-OCT examination.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparison of epithelial thickness between myopic and hyperopic eyes
Time Frame: At baseline (single visit)
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Corneal epithelial thickness will be compared between myopic and hyperopic eyes using AS-OCT measurements.
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At baseline (single visit)
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Comparison of epithelial thickness in eyes with and without astigmatism
Time Frame: At baseline (single visit)
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Corneal epithelial thickness will be evaluated and compared between eyes with astigmatism and those without astigmatism using AS-OCT.
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At baseline (single visit)
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Corneal epithelial thickness asymmetry across corneal regions and inter-eye comparison
Time Frame: At baseline (single visit)
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Epithelial thickness will be assessed across different corneal regions and compared between both eyes to evaluate inter-eye asymmetry.
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At baseline (single visit)
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Comparison of epithelial thickness in low and high refractive errors
Time Frame: At baseline (single visit)
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Corneal epithelial thickness profiles will be compared between low and high degrees of myopia and hyperopia using AS-OCT measurements.
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At baseline (single visit)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Engy Mohamed Mostafa, Professor, Department of Ophthalmology, Faculty of Medicine, Sohag University
- Study Director: 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 record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 1, 2026
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
May 1, 2027
Study Registration Dates
First Submitted
June 9, 2026
First Submitted That Met QC Criteria
June 9, 2026
First Posted (Actual)
June 15, 2026
Study Record Updates
Last Update Posted (Actual)
June 15, 2026
Last Update Submitted That Met QC Criteria
June 9, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-Med-26-5-7MS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Individual participant data will not be shared.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.