MyopiaNCT05548478
Corneal Endothelial Cell Injury Induced by Mitomycin-C
A study testing Transepithelial PRK/MMC and Alcohol-Assisted PRK/MMC in people with Myopia, run by Al-Azhar University at 1 site in Egypt.
Trial summary
our study will investigate the effecacy of Mitomycin-C in TransEpi single step photorefractive keratectomy (PRK) and alcohol assisted PRK Read more about this study
- Who is it for?
- Ages 17 to 50 years
- Conditions the study is for
- Myopia
- What is being tested?
- Transepithelial PRK/MMC and Alcohol-Assisted PRK/MMC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2022to Feb 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 17 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age over 18 years.
- Primary myopia or compound myopic astigmatism.
- Preoperative manifest refraction spherical equivalent (MRSE) within the range of -1.0 to 8 D
- Stable refractive error for at least 12 months before the surgery.
- Contact lens discontinuation for at least 3 weeks.
- Estimated corneal stromal bed thickness of more than 300mm at the thinnest point
Who cannot join
- Unwilling to participate in the study.
- Previous ocular surgery
- Any diagnosed ocular disease
- History of ocular trauma
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ehab tharwat
Damietta, New Damietta, 34517
ehab tharwat, MD, 01006952497 ext. 02, ehabtharwat71@gmail.com
About this study
Official title: Corneal Endothelial Cell Injury Induced by Mitomycin-C in TransEpi Single Step and Alcohol Assisted Photorefractive Keratectomy PRK: A Comparative Study
our study will investigate the effecacy of Mitomycin-C in TransEpi single step photorefractive keratectomy (PRK) and alcohol assisted PRK
- Conditions
- Myopia
- Being tested
- Transepithelial PRK/MMC, Alcohol-Assisted PRK/MMC
- Keywords
- mytomycin
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transepithelial PRK/MMCProcedure or surgery
transepithelial photorefractive keratectomy (PRK) and mitomycin C addition
Alcohol-Assisted PRK/MMCProcedure or surgery
photorefractive keratectomy (PRK) assisted by alchol and mitomycin C addition
| Study group | Role | What they receive |
|---|---|---|
| TransEpi single step PRK | Active comparator | Not described Receives: Procedure: Transepithelial PRK/MMC |
| alcohol assisted PRK | Active comparator | Not described Receives: Procedure: Alcohol-Assisted PRK/MMC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial cell Density
will be measured by Specular microscopy
Measured: Base line
Endothelial cell Density
will be measured by Specular microscopy
Measured: at 1st month
Endothelial cell Density
will be measured by Specular microscopy
Measured: at 3rd month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study startSep 2022 (estimated)
- Primary completionFeb 2023 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
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
- NCT05548478
- Sponsor's protocol ID
- Mitomycin-C
- Status last verified
- Sep 2022
- First submitted
- 17 Sep 2022
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corneal Endothelial Cell Injury Induced by Mitomycin-C in TransEpi Single Step and Alcohol Assisted Photorefractive Keratectomy PRK: A Comparative Study
- ClinicalTrials.gov ID
- NCT05548478
- Acronym / sponsor ID
- Mitomycin-C
- Conditions
- Myopia
- Keywords
- mytomycin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 21 Sep 2022 (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.
our study will investigate the effecacy of Mitomycin-C in TransEpi single step photorefractive keratectomy (PRK) and alcohol assisted PRK
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TransEpi single step PRK | Active comparator | Procedure: Transepithelial PRK/MMC |
| alcohol assisted PRK | Active comparator | Procedure: Alcohol-Assisted PRK/MMC |
Who may qualify
- Ages
- 17 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Age over 18 years.
- Primary myopia or compound myopic astigmatism.
- Preoperative manifest refraction spherical equivalent (MRSE) within the range of -1.0 to 8 D
- Stable refractive error for at least 12 months before the surgery.
- Contact lens discontinuation for at least 3 weeks.
Key exclusion criteria (4 listed)
- Unwilling to participate in the study.
- Previous ocular surgery
- Any diagnosed ocular disease
- History of ocular trauma
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 |
|---|---|---|
| Transepithelial PRK/MMCtransepithelial photorefractive keratectomy (PRK) and mitomycin C addition | Procedure or surgery | TransEpi single step PRK |
| Alcohol-Assisted PRK/MMCphotorefractive keratectomy (PRK) assisted by alchol and mitomycin C addition | Procedure or surgery | alcohol assisted PRK |
Primary outcome
Endothelial cell Density
Time frame: Base line
will be measured by Specular microscopy
Endothelial cell Density
Time frame: at 1st month
will be measured by Specular microscopy
Endothelial cell Density
Time frame: at 3rd month
will be measured by Specular microscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transepithelial PRK/MMC and Alcohol-Assisted PRK/MMC in people with Myopia, run by Al-Azhar 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 6 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: status not confirmed, as of the sponsor's last update on 21 Sep 2022. 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?
Endothelial cell Density (time frame: Base line). 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 21 Sep 2022.