KeratoconusNCT07426029
Effectiveness and Safety of Corneal Collagen Cross Linking After Induction of Stromal Emphysema in Keratoconus
A study testing Corneal collagen cross-linking with induction of corneal stromal emphysema in people with Keratoconus, run by Cairo University at 1 site in Egypt.
Trial summary
in this study we evaluated the effectiveness and safety of corneal collagen cross-linking in keratoconic eyes with thin cornea after induction of stromal emphysema prior to riboflavin instillation and UV-A corneal irradiation Read more about this study
- Who is it for?
- Ages 17 to 33 years
- Conditions the study is for
- Keratoconus
- What is being tested?
- Corneal collagen cross-linking with induction of corneal stromal emphysema
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2022to 1 Oct 2024
- 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 17 to 33 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Progressive KC proven by clinical examination, tomography, and pachymetry
- Thinnest corneal location thickness between 390 to 450 microns
Who cannot join
- Previous ocular Trauma or Surgery.
- History of herpetic eye disease
- Central corneal scarring
- Cornea guttata
- Ocular surface disease and dry eye disease
- Vernal and atopic keratoconjunctivitis
Show all 13Show fewer
- Cataract
- Glaucoma, intraocular pressure less than 10 or more than 21 mmHg
- Posterior segment abnormalities
- Nystagmus or other conditions that interfere with patient's fixation
- Diabetes mellitus
- pregnancy
- Collagen vascular disease, autoimmune disease and patients receiving immunosuppressive therapy
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of Ophthalmology-Faculty of Medicine-Cairo University
Giza, Giza Governorate, 11562
About this study
in this study we evaluated the effectiveness and safety of corneal collagen cross-linking in keratoconic eyes with thin cornea after induction of stromal emphysema prior to riboflavin instillation and UV-A corneal irradiation
- Conditions
- Keratoconus
- Being tested
- Corneal collagen cross-linking with induction of corneal stromal emphysema
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corneal collagen cross-linking with induction of corneal stromal emphysemaProcedure or surgery
Corneal collagen cross-linking with induction of corneal stromal emphysema
| Study group | Role | What they receive |
|---|---|---|
| Patients with progressive keratoconus | Other | Not described Receives: Procedure: Corneal collagen cross-linking with induction of corneal stromal emphysema |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluating effectiveness of Cross-linking in the presence of air in corneal stroma
Through serial corneal tomography
Measured: Corneal tomography will be performed preoperatively then 6, and 12 months after the procedure
Assessment of the safety of this procedure on corneal endothelial cells
By evaluating corneal endothelium structural integrity, using serial specular microscopy imaging
Measured: Specular microscopy will be performed preoperatively, then 1, 3 and 6 months after the procedure
Measuring demarcation line depth in microns from corneal epithelium
both reflectivity and depth (in microns) of demarcation line will be evaluated by using corneal OCT
Measured: one month after procedure
Secondary outcomes (1)
To detect changes in the visual acuity (in decimal)
Preoperative and postoperative examinations will be carried out for visual acuity, using Snellen visual acuity chart.
Measured: preoperatively then 1 week and 1, 3, 6, and 12 months after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start1 Oct 2022
- Primary completion1 Jul 2024
- Study completion1 Oct 2024
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 Cairo 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
- Model description
- prospective, interventional, case series
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Rashad Ashor, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07426029
- Sponsor's protocol ID
- MD-163-2023
- Status last verified
- Feb 2026
- First submitted
- 6 Jan 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets used and/or analyzed during this study are available from the principal investigator on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Corneal Collagen Cross Linking After Induction of Stromal Emphysema in Keratoconus
- ClinicalTrials.gov ID
- NCT07426029
- Acronym / sponsor ID
- MD-163-2023
- Conditions
- Keratoconus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 23 Feb 2026 (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.
in this study we evaluated the effectiveness and safety of corneal collagen cross-linking in keratoconic eyes with thin cornea after induction of stromal emphysema prior to riboflavin instillation and UV-A corneal irradiation
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective, interventional, case series
| Arm | Type | Receives |
|---|---|---|
| Patients with progressive keratoconus | Other | Procedure: Corneal collagen cross-linking with induction of corneal stromal emphysema |
Who may qualify
- Ages
- 17 to 33 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Progressive KC proven by clinical examination, tomography, and pachymetry
- Thinnest corneal location thickness between 390 to 450 microns
Key exclusion criteria (13 listed)
- Previous ocular Trauma or Surgery.
- History of herpetic eye disease
- Central corneal scarring
- Cornea guttata
- Ocular surface disease and dry eye disease
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 collagen cross-linking with induction of corneal stromal emphysemaCorneal collagen cross-linking with induction of corneal stromal emphysema | Procedure or surgery | Patients with progressive keratoconus |
Primary outcome
Evaluating effectiveness of Cross-linking in the presence of air in corneal stroma
Time frame: Corneal tomography will be performed preoperatively then 6, and 12 months after the procedure
Through serial corneal tomography
Assessment of the safety of this procedure on corneal endothelial cells
Time frame: Specular microscopy will be performed preoperatively, then 1, 3 and 6 months after the procedure
By evaluating corneal endothelium structural integrity, using serial specular microscopy imaging
Measuring demarcation line depth in microns from corneal epithelium
Time frame: one month after procedure
both reflectivity and depth (in microns) of demarcation line will be evaluated by using corneal OCT
1 secondary outcome
To detect changes in the visual acuity (in decimal)
Time frame: preoperatively then 1 week and 1, 3, 6, and 12 months after the procedure.
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 Feb 2026.
- Individual participant dataSharing planned: No. The datasets used and/or analyzed during this study are available from the principal investigator on reasonable request.
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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.
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 collagen cross-linking with induction of corneal stromal emphysema in people with Keratoconus, run by Cairo 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 13 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 Feb 2026. 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?
Evaluating effectiveness of Cross-linking in the presence of air in corneal stroma (time frame: Corneal tomography will be performed preoperatively then 6, and 12 months after the procedure). The study lists 3 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 Feb 2026.