Amount of Corneal Flattening (Kmax Flattening)NCT06549387
Topo-Pachymetric Customized Accelerated Epi-On Vs Accelerated Epi-Off Corneal Cross Linking in Keratoconus Management
A study testing Corneal cross linking in people with Amount of Corneal Flattening (Kmax Flattening) and Change in the Endothelial Cell Count, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
The objective of this study is to compare the clinical effectiveness and safety of Topo-Pachymetric Customized Accelerated Epithelium-On (aCFXL) to Standard Accelerated Epithelium-Off (aCXL) Corneal Collagen Cross-Linking in the management of keratoconus. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Amount of Corneal Flattening (Kmax Flattening), Change in the Endothelial Cell Count
- What is being tested?
- Corneal cross linking
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Aug 2024to 30 Apr 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 18 years or older
- Corrected distance visual acuity (CDVA) of ≥ 0.3 Snellen.
- Central corneal thickness (de-epithelialized) of ≥ 400 micron.
- Corneal endothelial count of ≥ 2000.
Who cannot join
- Previous eye surgery
- The presence of lesions other than keratoconus, central or paracentral scaring
- History of Cross linking
- History of viral keratitis
- Connective tissue diseases
- Pregnancy or lactation during the study.
- The presence of nystagmus
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Kasr Al Ainy
Cairo
Paula Sameh Youssef, M.Sc., 01286725750, paula.sameh77@gmail.com
About this study
Official title: Topo-Pachymetric Customized Accelerated Epithelium-On Versus Standard Accelerated Epithelium-Off Corneal Collagen Cross Linking in the Management of Keratoconus
The objective of this study is to compare the clinical effectiveness and safety of Topo-Pachymetric Customized Accelerated Epithelium-On (aCFXL) to Standard Accelerated Epithelium-Off (aCXL) Corneal Collagen Cross-Linking in the management of keratoconus. The study aims to evaluate visual and structural outcomes, to provide valuable insights into optimizing treatment strategies.
- Being tested
- Corneal cross linking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corneal cross linkingProcedure or surgery
Applying UVA irradiation to the cornea after soaking with riboflavin
| Study group | Role | What they receive |
|---|---|---|
| The topo-pachimetric customized accelerated epithelium-On (aCFXL group) | Active comparator | Not described Receives: Procedure: Corneal cross linking |
| The standard accelerated CXL (aCXL) protoco | Active comparator | Not described Receives: Procedure: Corneal cross linking |
| Progressive Fluence Epi-on accelerated crosslinking M nomogram | Active comparator | Not described Receives: Procedure: Corneal cross linking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of corneal flattening
Kmax flattening
Measured: 6 months
Change in the endothelial cell count.
the stability or decrease in the endothelial cell count.
Measured: 6 months
Secondary outcomes (1)
Best corrected visual acuity
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start15 Aug 2024 (estimated)
- Primary completion28 Feb 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amount of Corneal Flattening (Kmax Flattening)Studies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paula Sameh Youssef, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06549387
- Sponsor's protocol ID
- _MD-402-2023_
- Status last verified
- Aug 2024
- First submitted
- 8 Aug 2024
- Last updated
- 12 Aug 2024
- 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 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topo-Pachymetric Customized Accelerated Epithelium-On Versus Standard Accelerated Epithelium-Off Corneal Collagen Cross Linking in the Management of Keratoconus
- ClinicalTrials.gov ID
- NCT06549387
- Acronym / sponsor ID
- _MD-402-2023_
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 15 Aug 2024 (estimated)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 12 Aug 2024 (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 objective of this study is to compare the clinical effectiveness and safety of Topo-Pachymetric Customized Accelerated Epithelium-On (aCFXL) to Standard Accelerated Epithelium-Off (aCXL) Corneal Collagen Cross-Linking in the management of keratoconus. The study aims to evaluate visual and structural outcomes, to provide valuable insights into optimizing treatment strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The topo-pachimetric customized accelerated epithelium-On (aCFXL group) | Active comparator | Procedure: Corneal cross linking |
| The standard accelerated CXL (aCXL) protoco | Active comparator | Procedure: Corneal cross linking |
| Progressive Fluence Epi-on accelerated crosslinking M nomogram | Active comparator | Procedure: Corneal cross linking |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: 18 years or older
- Corrected distance visual acuity (CDVA) of ≥ 0.3 Snellen.
- Central corneal thickness (de-epithelialized) of ≥ 400 micron.
- Corneal endothelial count of ≥ 2000.
Key exclusion criteria (7 listed)
- Previous eye surgery
- The presence of lesions other than keratoconus, central or paracentral scaring
- History of Cross linking
- History of viral keratitis
- Connective tissue diseases
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 |
|---|---|---|
| Corneal cross linkingApplying UVA irradiation to the cornea after soaking with riboflavin | Procedure or surgery | Progressive Fluence Epi-on accelerated crosslinking M nomogram, The standard accelerated CXL (aCXL) protoco, The topo-pachimetric customized accelerated epithelium-On (aCFXL group) |
Primary outcome
Amount of corneal flattening
Time frame: 6 months
Kmax flattening
Change in the endothelial cell count.
Time frame: 6 months
the stability or decrease in the endothelial cell count.
1 secondary outcome
Best corrected visual acuity
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Corneal cross linking in people with Amount of Corneal Flattening (Kmax Flattening) and Change in the Endothelial Cell Count, run by Kasr El Aini Hospital at 1 site 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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of corneal flattening (time frame: 6 months). The study lists 2 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 12 Aug 2024.