KeratoconusNCT07080983
Efficacy of Corneal Cross-Linking (CXL) in the Treatment of Pediatric Keratoconus
A study testing Crosslinking in people with Keratoconus, run by Al-Azhar University at 2 sites in Egypt.
Trial summary
This prospective interventional study investigates the efficacy of corneal cross-linking (CXL) in managing progressive keratoconus in pediatric patients. The procedure involved standard epithelium-off CXL, and patients were followed to assess outcomes such as visual acuity, keratometric stability, and corneal… Read more about this study
- Who is it for?
- Ages 10 to 20 years
- Conditions the study is for
- Keratoconus
- What is being tested?
- Crosslinking
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesEgypt
- Study dates
- 2 Apr 2024to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 10 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age between 8 and 18 years
- Clinical and topographic diagnosis of keratoconus based on the Belin/Ambrosio Enhanced Ectasia Display
- Evidence of progression within the past 6-12 months (e.g., an increase in maximum keratometry (Kmax) by ≥1.0 diopter, a decrease in minimal corneal thickness by ≥10 µm, or deterioration in visual acuity not attributable to other causes
Who cannot join
- Corneal scarring or opacities.
- Active ocular infection or inflammation.
- Prior ocular surgery or trauma.
- Autoimmune or connective tissue disorders.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Ehab tharwat
Damietta, New Damietta, 34517
Al-Azhar university
Damietta
About this study
This prospective interventional study investigates the efficacy of corneal cross-linking (CXL) in managing progressive keratoconus in pediatric patients. The procedure involved standard epithelium-off CXL, and patients were followed to assess outcomes such as visual acuity, keratometric stability, and corneal thickness.
- Conditions
- Keratoconus
- Being tested
- Crosslinking
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CrosslinkingProcedure or surgery
Corneal Cross-Linking (CXL) is a minimally invasive procedure used to strengthen the cornea by increasing the chemical bonds between collagen fibers. It is primarily used to treat keratoconus and corneal ectasia, conditions where the cornea becomes progressively thinner and weaker.
| Study group | Role | What they receive |
|---|---|---|
| Cross-linking | Other | Not described Receives: Procedure: Crosslinking |
What is being measured
The primary outcome is the main question the study is designed to answer.
keratometry (Kmax)
Kmax (Maximum Keratometry) is the steepest point of curvature on the cornea, and it is a key parameter in diagnosing and monitoring keratoconus.
Measured: Baseline
keratometry (Kmax)
Kmax (Maximum Keratometry) is the steepest point of curvature on the cornea, and it is a key parameter in diagnosing and monitoring keratoconus.
Measured: After 12 months
BCVA
Measurment of the visual acuity
Measured: Baseline
BCVA
Measurment of the visual acuity
Measured: After 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start2 Apr 2024
- Primary completion2 May 2025
- Study completion1 Jul 2025
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 Al-Azhar 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ehab Tharwat, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07080983
- Sponsor's protocol ID
- Pediatric Keratoconus
- Status last verified
- Jul 2025
- First submitted
- 15 Jul 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Corneal Cross-Linking (CXL) in the Treatment of Pediatric Keratoconus
- ClinicalTrials.gov ID
- NCT07080983
- Acronym / sponsor ID
- Pediatric Keratoconus
- Conditions
- Keratoconus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 2 May 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 23 Jul 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.
This prospective interventional study investigates the efficacy of corneal cross-linking (CXL) in managing progressive keratoconus in pediatric patients. The procedure involved standard epithelium-off CXL, and patients were followed to assess outcomes such as visual acuity, keratometric stability, and corneal thickness.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cross-linking | Other | Procedure: Crosslinking |
Who may qualify
- Ages
- 10 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age between 8 and 18 years
- Clinical and topographic diagnosis of keratoconus based on the Belin/Ambrosio Enhanced Ectasia Display
- Evidence of progression within the past 6-12 months (e.g., an increase in maximum keratometry (Kmax) by ≥1.0 diopter, a decrease in minimal corneal thickness by ≥10 µm, or deterioration in visual acuity not attributable to other causes
Key exclusion criteria (4 listed)
- Corneal scarring or opacities.
- Active ocular infection or inflammation.
- Prior ocular surgery or trauma.
- Autoimmune or connective tissue disorders.
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 |
|---|---|---|
| CrosslinkingCorneal Cross-Linking (CXL) is a minimally invasive procedure used to strengthen the cornea by increasing the chemical bonds between collagen fibers. It is primarily used to treat keratoconus and corneal ectasia, conditions where the cornea becomes progressively thinner and weaker. | Procedure or surgery | Cross-linking |
Primary outcome
keratometry (Kmax)
Time frame: Baseline
Kmax (Maximum Keratometry) is the steepest point of curvature on the cornea, and it is a key parameter in diagnosing and monitoring keratoconus.
keratometry (Kmax)
Time frame: After 12 months
Kmax (Maximum Keratometry) is the steepest point of curvature on the cornea, and it is a key parameter in diagnosing and monitoring keratoconus.
BCVA
Time frame: Baseline
Measurment of the visual acuity
BCVA
Time frame: After 12 months
Measurment of the visual acuity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Proof-of-Concept for a Novel Optical Aperture Contact Lens in Presbyopia and Keratoconus
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A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
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Enrolling by invitationObservational study
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Crosslinking in people with Keratoconus, run by Al-Azhar University at 2 sites in Egypt.
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 3 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: finished, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
keratometry (Kmax) (time frame: Baseline). The study lists 4 primary outcomes in all. 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 23 Jul 2025.