Corneal Thickness MeasurementNCT06905977
Thick Cornea with High Back Elevation
An observational study of Corneal Thickness Measurement, run by Assiut University.
Trial summary
To follow up cases of thick cornea with high back elevation by pentacam. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Corneal Thickness Measurement
- What is being tested?
- pentacam
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to Jun 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 6 years and older
- All sexes
- Child, Adult, Older adult
Study population: any age can interact with pentacam device
Who may be able to join
- Any patient can interact with pentacam. Both Genders: include both males and females. Patients with thick cornea (>540 µm) with high back elevation.
Who cannot join
- Patients with any eye disease (significant cataract or unstable glaucoma)
- Uncontrolled external disease such as blepharitis , moderate to severe dry eye and allergy.
- Patient with ocular disease such as uveitis, post herpetic infection and corneal opacity
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Long Term Follow-up Study on Thick Cornea with High Back Elevation
To follow up cases of thick cornea with high back elevation by pentacam.
Read the detailed description
The cornea plays a crucial role in refraction and so help in good visual acuity. with its thickness and back elevation being essential parameters in diagnosing and managing corneal diseases such as keratoconus.
The normal human cornea has a central thickness of approximately 540-550 µm. The periphery is generally thicker, reaching up to 700 µm. Corneal thickness is influenced by genetics, hydration, and intraocular pressure.Thick Cornea (> 540 µm): Seen in conditions such as corneal edema and Fuchs' dystrophy. Thin Cornea (< 500 µm): Observed in keratoconus, LASIK-induced thinning, and corneal ectasia.
Back corneal elevation is assessed using corneal topography or tomography, typically referenced to a best-fit sphere (BFS). In normal cases, Back corneal elevation is usually ≤12 µm above the BFS, indicating a structurally healthy cornea without signs of ectasia. Susceptible elevation ranges between 12-20 µm, which may be an early indicator of corneal instability, such as subclinical keratoconus. Therefore, it should be evaluated alongside other parameters, including pachymetry, anterior curvature, and biomechanical properties. Abnormal back corneal elevation is generally considered >20 µm, particularly if localized or asymmetric, and is strongly associated with corneal ectatic disorders such as keratoconus, pellucid marginal degeneration, or post-LASIK ectasia. This abnormal elevation is often accompanied by other risk factors, including increased posterior corneal curvature, corneal thinning, and significant asymmetry, necessitating further assessment and monitoring.
Many cases of thick cornea are associated with high back elevation and this discourage refractive surgery in such cases so in investigator's study the investigator will follow up these cases to determine if these corneas are considered normal corneas or not.
- Conditions
- Corneal Thickness Measurement
- Being tested
- pentacam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pentacamDevice
we will follow up on cases of thick cornea with high back elevation
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of corneal thickness and back corneal elevation by pentacam device
The investigator will image the cornea to measure corneal thickness and back corneal elevation using the Pentacam device and follow up for cases of thick corneas with high back elevation at 3 months, 6 months, and 1 year.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start1 May 2025 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal Thickness MeasurementStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merna Magdy Fily, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06905977
- Sponsor's protocol ID
- Thick cornea
- Status last verified
- Mar 2025
- First submitted
- 14 Mar 2025
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Follow-up Study on Thick Cornea with High Back Elevation
- ClinicalTrials.gov ID
- NCT06905977
- Acronym / sponsor ID
- Thick cornea
- Conditions
- Corneal Thickness Measurement
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 2 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.
To follow up cases of thick cornea with high back elevation by pentacam.
Detailed description
The cornea plays a crucial role in refraction and so help in good visual acuity. with its thickness and back elevation being essential parameters in diagnosing and managing corneal diseases such as keratoconus.
The normal human cornea has a central thickness of approximately 540-550 µm. The periphery is generally thicker, reaching up to 700 µm. Corneal thickness is influenced by genetics, hydration, and intraocular pressure.Thick Cornea (> 540 µm): Seen in conditions such as corneal edema and Fuchs' dystrophy. Thin Cornea (< 500 µm): Observed in keratoconus, LASIK-induced thinning, and corneal ectasia.
Back corneal elevation is assessed using corneal topography or tomography, typically referenced to a best-fit sphere (BFS). In normal cases, Back corneal elevation is usually ≤12 µm above the BFS, indicating a structurally healthy cornea without signs of ectasia. Susceptible elevation ranges between 12-20 µm, which may be an early indicator of corneal instability, such as subclinical keratoconus. Therefore, it should be evaluated alongside other parameters, including pachymetry, anterior curvature, and biomechanical properties. Abnormal back corneal elevation is generally considered >20 µm, particularly if localized or asymmetric, and is strongly associated with corneal ectatic disorders such as keratoconus, pellucid marginal degeneration, or post-LASIK ectasia. This abnormal elevation is often accompanied by other risk factors, including increased posterior corneal curvature, corneal thinning, and significant asymmetry, necessitating further assessment and monitoring.
Many cases of thick cornea are associated with high back elevation and this discourage refractive surgery in such cases so in investigator's study the investigator will follow up these cases to determine if these corneas are considered normal corneas or not.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- any age can interact with pentacam device
Key inclusion criteria (1 listed)
- Any patient can interact with pentacam. Both Genders: include both males and females. Patients with thick cornea (>540 µm) with high back elevation.
Key exclusion criteria (3 listed)
- Patients with any eye disease (significant cataract or unstable glaucoma)
- Uncontrolled external disease such as blepharitis , moderate to severe dry eye and allergy.
- Patient with ocular disease such as uveitis, post herpetic infection and corneal opacity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pentacamwe will follow up on cases of thick cornea with high back elevation | Device | – |
Primary outcome
Measurement of corneal thickness and back corneal elevation by pentacam device
Time frame: Baseline
The investigator will image the cornea to measure corneal thickness and back corneal elevation using the Pentacam device and follow up for cases of thick corneas with high back elevation at 3 months, 6 months, and 1 year.
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 2 Apr 2025.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Corneal Thickness Measurement, 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 1 inclusion and 3 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 2 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?
Contact Merna Fily (01226081248, mernamagdyfily24@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of corneal thickness and back corneal elevation by pentacam device (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 2 Apr 2025.