Thin Suspicious CorneaNCT07277348
Analysis of The Outcomes of Therapeutic Photorefractive Keratectomy Combined With Prophylactic Accelerated Cross-Linking (PRK-Plus), for Treatment of Thin Suspicious Cornea
A study testing PRK PLUS in people with Thin Suspicious Cornea, run by Fayoum University.
Trial summary
analyze the outcomes of therapeutic photorefractive keratectomy combined with prophylactic accelerated cross-linking (PRK-Plus), for treatment of thin suspicious cornea Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Thin Suspicious Cornea
- What is being tested?
- PRK PLUS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 1 Mar 2027
- Phase
- Interventional
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- CCT less than 490 microns
- K mean more than 46 and/or K max more than 47.
- Astigmatism cylinder >1.5 D.
- D value of Belin/Ambrósio Module > 1.6
- inferior- superior asymmetry or bow-tie pattern with skewed radial axes on tangential maps and abnormal changes on (BAD).
- Asymmetry topography between 2 eyes, even if neither eye"s topographic pattern is in itself decidedly abnormal.
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- Any significant skewed radial axis with or without inferior steepening, or one diopter or more of inferior steepening in some areas but an I-S value of ,1.4,7.
- young patients with against-the-rule astigmatic patterns.
- a PTA value 40% if calculated.
- Abnormal Topographic Patterns
- K2 reading of corneal back surface less than [-7].
- D Value of CSTP > 2.5 in Belin/Ambrósio curve
- We look at values within the central 5 mm circle; the map should be displayed in the BFTE float mode with an estimated area of 8 mm of diameter:
- Elevation values on the front surface values > +12 μ
- Elevation values on the back surface values >+15 μ.
- If there is any isolated island on either front or back surfaces (in the BFS float mode)
Who cannot join
- Eyes diagnosed with KC.
- CCT less than 450 microns
About this study
Official title: Analysis of The Outcomes of Therapeutic Photorefractive Keratectomy Combined With Prophylactic Accelerated Cross-Linking (PRK-Plus), for Treatment of Thin Suspicious Cornea: Short-Term Pilot Study
analyze the outcomes of therapeutic photorefractive keratectomy combined with prophylactic accelerated cross-linking (PRK-Plus), for treatment of thin suspicious cornea
- Conditions
- Thin Suspicious Cornea
- Being tested
- PRK PLUS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRK PLUSProcedure or surgery
therapeutic photorefractive keratectomy combined with prophylactic accelerated cross-linking
| Study group | Role | What they receive |
|---|---|---|
| PRK PLUS | Experimental | PRK PLUS Receives: Procedure: PRK PLUS |
| Follow up group | No intervention | follow up with pentacam |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual acuity improvement measured by LogMAR system
visual acuity improvement measured by LogMAR system
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start1 Feb 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thin Suspicious CorneaStudies of the same condition, open and under way.
- More trials run by Fayoum 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Said, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07277348
- Sponsor's protocol ID
- PRK PLUS in thin cornea
- Status last verified
- Nov 2025
- First submitted
- 28 Nov 2025
- Last updated
- 11 Dec 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 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of The Outcomes of Therapeutic Photorefractive Keratectomy Combined With Prophylactic Accelerated Cross-Linking (PRK-Plus), for Treatment of Thin Suspicious Cornea: Short-Term Pilot Study
- ClinicalTrials.gov ID
- NCT07277348
- Acronym / sponsor ID
- PRK PLUS in thin cornea
- Conditions
- Thin Suspicious Cornea
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 11 Dec 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.
analyze the outcomes of therapeutic photorefractive keratectomy combined with prophylactic accelerated cross-linking (PRK-Plus), for treatment of thin suspicious cornea
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRK PLUS | Experimental | Procedure: PRK PLUSPRK PLUS |
| Follow up group | No intervention | –follow up with pentacam |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- CCT less than 490 microns
- K mean more than 46 and/or K max more than 47.
- Astigmatism cylinder >1.5 D.
- D value of Belin/Ambrósio Module > 1.6
- inferior- superior asymmetry or bow-tie pattern with skewed radial axes on tangential maps and abnormal changes on (BAD).
Key exclusion criteria (2 listed)
- Eyes diagnosed with KC.
- CCT less than 450 microns
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 |
|---|---|---|
| PRK PLUStherapeutic photorefractive keratectomy combined with prophylactic accelerated cross-linking | Procedure or surgery | PRK PLUS |
Primary outcome
visual acuity improvement measured by LogMAR system
Time frame: 1 year
visual acuity improvement measured by LogMAR system
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 11 Dec 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing PRK PLUS in people with Thin Suspicious Cornea, run by Fayoum 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 16 inclusion and 2 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 11 Dec 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?
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?
visual acuity improvement measured by LogMAR system (time frame: 1 year). 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 11 Dec 2025.