KeratoconusNCT06914973
Evaluation of Corneal Epithelial Mapping in Diagnosis of Early Keratoconus by Anterior Segment Optical Coherence Tomography
An observational study of Keratoconus, run by Assiut University.
Trial summary
The cornea, as the outermost refractive structure of the eye, plays a critical role in maintaining clear vision. Its transparency and structural integrity are essential for optimal visual function. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Keratoconus
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 1 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients will be divided into three groups: healthy individuals , patients with keratoconus and suspicious keratoconus patient
Who may be able to join
- • Healthy participants with normal corneal topography and no ocular abnormalities intended to do LASIK.
- Keratoconus patients with a confirmed diagnosis (based on corneal topography, tomography, and clinical signs).
- Suspicious Keratoconus patients by pentacam.
- Age ≥ 18 years.
- Willingness to provide informed consent.
Who cannot join
- • History of corneal surgery or trauma.
- Active ocular infection or inflammation.
- Severe dry eye disease or other conditions affecting corneal epithelium.
- Inability to cooperate with imaging procedures.
About this study
The cornea, as the outermost refractive structure of the eye, plays a critical role in maintaining clear vision. Its transparency and structural integrity are essential for optimal visual function. Among the layers of the cornea, the corneal epithelium is of particular interest due to its dynamic nature and its ability to remodel in response to various physiological and pathological conditions. Accurate and repeatable measurement of corneal epithelial thickness (CET) is therefore crucial for diagnosing and managing corneal diseases, such as keratoconus, and for planning refractive surgeries Keratoconus, a progressive corneal ectatic disorder, is characterized by thinning and protrusion of the cornea, leading to irregular astigmatism and visual impairment. Early detection and monitoring of keratoconus rely heavily on precise corneal imaging, including CET mapping. While AS-OCT has shown promise in evaluating CET in both healthy and keratoconic eyes, the repeatability of these measurements must be thoroughly evaluated to ensure their clinical utility Early diagnosis with subsequent corneal crosslinking (CXL) can slow-down or stop keratoconus progression.9 Identifying subclinical keratoconus is extremely important in refractive surgery screening to avoid iatrogenic ectasia. Anterior and posterior corneal topography combined with total cornea thickness measurements and localisation of the thinnest area are the parameters used commonly for diagnosing and staging of corneal ectasias. Recently, epithelial thickness is also added as an additional parameter and is shown to be useful for both early diagnosis and grading of keratoconus Corneal imaging is an essential tool in modern eye care. Initially, the curvature of the anterior corneal surface constituted the ground for the estimation of corneal optical properties and diagnosis of ectatic disorders like keratoconus. Gradually the importance of the posterior corneal curvature as well as its thickness gained significance. In recent years, new imaging devices allowing fast and high-resolution imaging of the entire anterior segment, cornea included started to emerge. The main advantages of the new generation Anterior Segment Optical Coherence Tomography (AS-OCT) are their superior acquisition speed, improved optical resolution (axial and transversal), as well as scanning depth and field of view .
High-resolution imaging of the cornea with AS-OCT provides thickness measurements individually for epithelium and stroma individually. Measuring corneal epithelial thickness adds information that could be of value in early diagnosis, progression evaluation and maybe even for a more complete understanding of the pathophysiology of this disease. It has been shown that changes in the corneal epithelial thickness could be a sensitive tool for early keratoconus detection as well as for the assessment of the disease progression.
Read more
Precise measurements of the epithelial thickness are therefore important for keratoconus diagnosis and follow-up. AS-OCTs have high axial resolution and studies have shown that these instruments provide repeatable epithelial measurements both in central and peripheral cornea. With an additional lens (anterior segment module), posterior segments OCTs can also be used to measure corneal parameters including epithelial thickness1and previous studies have shown that these modules can also produce precise epithelial thickness measurements in healthy corneas and in keratoconus. There is only limited information on how the precision of epithelial measurements with the anterior module in posterior segment OCTs compares to the precision of epithelial measurements with AS-OCTs Aim of this study Detect early-stage keratoconus by identifying suitable epithelial thickness changes before topographic abnormalities appear .
- Provide higher accuracy compared to traditional topography by offering high-resolution cross-sectional imaging
- Conditions
- Keratoconus
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Control Group who intended to do LASIK (N=50) | |
| Group II | Keratoconus Group (N=50) | |
| Group III | Suspicious keratoconus by pentacam ( N=50) |
What is being measured
The primary outcome is the main question the study is designed to answer.
epithelial thickness maps
From the pachymetry map, we measured the central corneal thickness, and from the epithelial map, we measured central epithelial thickness, thickest location, thinnest location, and their distributionespecially in its subclinical or early stages.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2025
- Study start1 May 2025 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeratoconusStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Refaat Nagib, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06914973
- Sponsor's protocol ID
- mapping keratoconus OCT
- Status last verified
- Apr 2025
- First submitted
- 25 Mar 2025
- Last updated
- 7 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Corneal Epithelial Mapping in Diagnosis of Early Keratoconus by Anterior Segment Optical Coherence Tomography
- ClinicalTrials.gov ID
- NCT06914973
- Acronym / sponsor ID
- mapping keratoconus OCT
- Conditions
- Keratoconus
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 7 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The cornea, as the outermost refractive structure of the eye, plays a critical role in maintaining clear vision. Its transparency and structural integrity are essential for optimal visual function. Among the layers of the cornea, the corneal epithelium is of particular interest due to its dynamic nature and its ability to remodel in response to various physiological and pathological conditions. Accurate and repeatable measurement of corneal epithelial thickness (CET) is therefore crucial for diagnosing and managing corneal diseases, such as keratoconus, and for planning refractive surgeries Keratoconus, a progressive corneal ectatic disorder, is characterized by thinning and protrusion of the cornea, leading to irregular astigmatism and visual impairment. Early detection and monitoring of keratoconus rely heavily on precise corneal imaging, including CET mapping. While AS-OCT has shown promise in evaluating CET in both healthy and keratoconic eyes, the repeatability of these measurements must be thoroughly evaluated to ensure their clinical utility Early diagnosis with subsequent corneal crosslinking (CXL) can slow-down or stop keratoconus progression.9 Identifying subclinical keratoconus is extremely important in refractive surgery screening to avoid iatrogenic ectasia. Anterior and posterior corneal topography combined with total cornea thickness measurements and localisation of the thinnest area are the parameters used commonly for diagnosing and staging of corneal ectasias. Recently, epithelial thickness is also added as an additional parameter and is shown to be useful for both early diagnosis and grading of keratoconus Corneal imaging is an essential tool in modern eye care. Initially, the curvature of the anterior corneal surface constituted the ground for the estimation of corneal optical properties and diagnosis of ectatic disorders like keratoconus. Gradually the importance of the posterior corneal curvature as well as its thickness gained significance. In recent years, new imaging devices allowing fast and high-resolution imaging of the entire anterior segment, cornea included started to emerge. The main advantages of the new generation Anterior Segment Optical Coherence Tomography (AS-OCT) are their superior acquisition speed, improved optical resolution (axial and transversal), as well as scanning depth and field of view .
High-resolution imaging of the cornea with AS-OCT provides thickness measurements individually for epithelium and stroma individually. Measuring corneal epithelial thickness adds information that could be of value in early diagnosis, progression evaluation and maybe even for a more complete understanding of the pathophysiology of this disease. It has been shown that changes in the corneal epithelial thickness could be a sensitive tool for early keratoconus detection as well as for the assessment of the disease progression.
Precise measurements of the epithelial thickness are therefore important for keratoconus diagnosis and follow-up. AS-OCTs have high axial resolution and studies have shown that these instruments provide repeatable epithelial measurements both in central and peripheral cornea. With an additional lens (anterior segment module), posterior segments OCTs can also be used to measure corneal parameters including epithelial thickness1and previous studies have shown that these modules can also produce precise epithelial thickness measurements in healthy corneas and in keratoconus. There is only limited information on how the precision of epithelial measurements with the anterior module in posterior segment OCTs compares to the precision of epithelial measurements with AS-OCTs Aim of this study Detect early-stage keratoconus by identifying suitable epithelial thickness changes before topographic abnormalities appear .
- Provide higher accuracy compared to traditional topography by offering high-resolution cross-sectional imaging
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I | – | –Control Group who intended to do LASIK (N=50) |
| Group II | – | –Keratoconus Group (N=50) |
| Group III | – | –Suspicious keratoconus by pentacam ( N=50) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients will be divided into three groups: healthy individuals , patients with keratoconus and suspicious keratoconus patient
Key inclusion criteria (5 listed)
- • Healthy participants with normal corneal topography and no ocular abnormalities intended to do LASIK.
Key exclusion criteria (4 listed)
- • History of corneal surgery or trauma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
epithelial thickness maps
Time frame: baseline
From the pachymetry map, we measured the central corneal thickness, and from the epithelial map, we measured central epithelial thickness, thickest location, thinnest location, and their distributionespecially in its subclinical or early stages.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Keratoconus, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
epithelial thickness maps (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2025.