Corneal EctasiaNCT05691335
Three Different Cross-linking Protocols for Treatment of Pediatric Keratoconus
A study testing Standard CXL, Accelerated CXL and Transepithelial CXL in people with Corneal Ectasia, run by Sohag University at 1 site in Egypt.
Trial summary
comparison between standard cross-linking protocol and accelerated and transepithelial cross-linking Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Corneal Ectasia
- What is being tested?
- Standard CXL, Accelerated CXL and Transepithelial CXL
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2018to 5 Jan 2023
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- pediatric patient less than 18 years old
- keratoconus stage I-III ABCD keratoconus grading system
Who cannot join
- age more than 18 years
- previous eye surgery
- current eye infection or pathology
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of the Outcomes of Three Different Cross-linking Protocols for Treatment of Pediatric Keratoconus
comparison between standard cross-linking protocol and accelerated and transepithelial cross-linking
Read the detailed description
comparison between standard cross-linking protocol and accelerated and transepithelial cross-linking for treatment of documented pediatric keratoconus progression. The study patients are divided into 3 groups. Group A patient treated with standard cross-linking. Group B patients treated with accelerated cross-linking. Group C patients treated with transepithelial cross-linking.
- Conditions
- Corneal Ectasia
- Being tested
- Standard CXL, Accelerated CXL, Transepithelial CXL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard CXLProcedure or surgery
Epithelium-off CXL performed by removal of corneal epithelium, instillation of riboflavin onto the cornea followed by UVA corneal irradiation for 30 minutes.
Accelerated CXLProcedure or surgery
Epithelium-off CXL performed by removal of corneal epithelium, instillation of riboflavin onto the cornea followed by UVA corneal irradiation for 5 minutes.
Transepithelial CXLProcedure or surgery
Epithelium-on CXL performed by instillation of riboflavin onto the cornea followed by UVA corneal irradiation for 5 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Standard CXL | Other | Patients treated according to Dresden Protocol with epithelium-off CXL. Receives: Procedure: Standard CXL |
| Accelerated CXL | Experimental | Patients treated according to accelerated Protocol with epithelium-off CXL. Receives: Procedure: Accelerated CXL |
| Transepithelial CXL | Experimental | Patients treated according to transepithelial Protocol with epithelium-on CXL. Receives: Procedure: Transepithelial CXL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uncorrected distance visual acuity
measured in logarithm of minimal angle of resolution (logMAR)
Measured: 36 months
Corrected distance visual acuity
measured in logarithm of minimal angle of resolution (logMAR)
Measured: 36 months
Sphere
measured in diopters (D)
Measured: 36 months
Cylinder
measured in diopters (D)
Measured: 36 months
Keratometry (Kmax)
measured in diopters (D)
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start1 Jun 2018
- Primary completion1 Jan 2023
- Study completion5 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal EctasiaStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Mohammed Iqbal, Sohag University
- Investigators
- Mohammed Iqbal, MD, PhD, Principal investigator, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05691335
- Sponsor's protocol ID
- 10-4/2018
- Status last verified
- Mar 2023
- First submitted
- 7 Jan 2023
- Last updated
- 31 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Outcomes of Three Different Cross-linking Protocols for Treatment of Pediatric Keratoconus
- ClinicalTrials.gov ID
- NCT05691335
- Acronym / sponsor ID
- 10-4/2018
- Conditions
- Corneal Ectasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 5 Jan 2023 (actual)
- First posted
- 20 Jan 2023 (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.
comparison between standard cross-linking protocol and accelerated and transepithelial cross-linking
Detailed description
comparison between standard cross-linking protocol and accelerated and transepithelial cross-linking for treatment of documented pediatric keratoconus progression. The study patients are divided into 3 groups. Group A patient treated with standard cross-linking. Group B patients treated with accelerated cross-linking. Group C patients treated with transepithelial cross-linking.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard CXL | Other | Procedure: Standard CXLPatients treated according to Dresden Protocol with epithelium-off CXL. |
| Accelerated CXL | Experimental | Procedure: Accelerated CXLPatients treated according to accelerated Protocol with epithelium-off CXL. |
| Transepithelial CXL | Experimental | Procedure: Transepithelial CXLPatients treated according to transepithelial Protocol with epithelium-on CXL. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- pediatric patient less than 18 years old
- keratoconus stage I-III ABCD keratoconus grading system
Key exclusion criteria (3 listed)
- age more than 18 years
- previous eye surgery
- current eye infection or pathology
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 |
|---|---|---|
| Standard CXLEpithelium-off CXL performed by removal of corneal epithelium, instillation of riboflavin onto the cornea followed by UVA corneal irradiation for 30 minutes. | Procedure or surgery | Standard CXL |
| Accelerated CXLEpithelium-off CXL performed by removal of corneal epithelium, instillation of riboflavin onto the cornea followed by UVA corneal irradiation for 5 minutes. | Procedure or surgery | Accelerated CXL |
| Transepithelial CXLEpithelium-on CXL performed by instillation of riboflavin onto the cornea followed by UVA corneal irradiation for 5 minutes. | Procedure or surgery | Transepithelial CXL |
Primary outcome
Uncorrected distance visual acuity
Time frame: 36 months
measured in logarithm of minimal angle of resolution (logMAR)
Corrected distance visual acuity
Time frame: 36 months
measured in logarithm of minimal angle of resolution (logMAR)
Sphere
Time frame: 36 months
measured in diopters (D)
Cylinder
Time frame: 36 months
measured in diopters (D)
Keratometry (Kmax)
Time frame: 36 months
measured in diopters (D)
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 31 Mar 2023.
Related trials for Corneal Ectasia
RecruitingObservational study
A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
Keratoconus, Ectasia
RecruitingPhase 2/3
Corneal Crosslinking for Treatment of Progressive Keratoconus or Corneal Ectasia
Keratoconus, Corneal Ectasia
RecruitingObservational study
Corneal Elastography and Patient Specific Modeling
Cornea; Ectasia, Refractive Errors
Not yet recruitingPhase 4
Outcomes of CTAK Surgery
Keratoconus, Corneal Ectasia
RecruitingPhase 3
Comparison of Epi-ON Corneal Collagen Crosslinking Performed Using an 18-Minute UVA Exposure vs. a 24-Minute UVA Exposure on Eyes With Ectatic Corneal Diseases
Keratoconus, Ectasia of Cornea
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.
Mohammed Iqbal, MD, PhD principal investigator
Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard CXL, Accelerated CXL and Transepithelial CXL in people with Corneal Ectasia, run by Sohag University 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 2 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: finished, as of the sponsor's last update on 31 Mar 2023. 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?
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?
Uncorrected distance visual acuity (time frame: 36 months). The study lists 5 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 31 Mar 2023.