MyopiaPhase 1NCT00999973
Study on the Effect of Mitomycin C 0.02% on the Corneal Endothelial After Photorefractive Keratectomy in Moderate Myopia
A Phase 1 study testing Mitomycin C 0.02% in people with Myopia, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
In this study 126 eyes in 63 patients with moderate bilateral myopia and astigmatism between -3 and -5 (SE difference between two eyes should not be more than 0.75 and the residual corneal thickness>350 μ ) were entered in the study. Read more about this study
- Who is it for?
- Ages 19 to 60 years
- Conditions the study is for
- Myopia
- What is being tested?
- Mitomycin C 0.02%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 1 siteIran
- Study dates
- Sep 2009to not given
- Phase
- Phase 1
- 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 19 to 60 years
- All sexes
- Adult
Who may be able to join
- 19 < age < 60
- Refractory error stabled for at least one year
- No corneal pathology
- -3 < bilateral myopia and astigmatism < -5 with no difference more than 0.75 between 2 eyes
Who cannot join
- Keratoconus
- Ectatic corneal disease
- Glaucoma
- Corneal dystrophy
- Lens changes affecting the visual acuity
- Anterior or posterior uveitis
- Corneal scar
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Ophthalmic Research Center
Tehran, 166666
Mohammad Ali Javadi, MD
About this study
In this study 126 eyes in 63 patients with moderate bilateral myopia and astigmatism between -3 and -5 (SE difference between two eyes should not be more than 0.75 and the residual corneal thickness>350 μ ) were entered in the study. One eye went randomly under PRK with mitomycin C 0.02% in 15 min and then the other eye went under the operation without MMC. UCVA,BCVA, refractory error after the operation and the number of endothelial cells before and after the surgery would be compared in 6 months.
- Conditions
- Myopia
- Being tested
- Mitomycin C 0.02%, Placebo
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitomycin C 0.02%Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Mitomycin c 0.02% | Active comparator | Not described Receives: Drug: Mitomycin C 0.02% |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2009 (estimated)
- Study startSep 2009
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.
- 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 1
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00999973
- Sponsor's protocol ID
- 8804
- Status last verified
- Oct 2009
- First submitted
- 13 Oct 2009
- Last updated
- 22 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effect of Mitomycin C 0.02% on the Corneal Endothelial After Photorefractive Keratectomy in Moderate Myopia
- ClinicalTrials.gov ID
- NCT00999973
- Acronym / sponsor ID
- 8804
- Conditions
- Myopia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Sep 2009
- First posted
- 22 Oct 2009 (estimated)
- 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 126 eyes in 63 patients with moderate bilateral myopia and astigmatism between -3 and -5 (SE difference between two eyes should not be more than 0.75 and the residual corneal thickness>350 μ ) were entered in the study. One eye went randomly under PRK with mitomycin C 0.02% in 15 min and then the other eye went under the operation without MMC. UCVA,BCVA, refractory error after the operation and the number of endothelial cells before and after the surgery would be compared in 6 months.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mitomycin c 0.02% | Active comparator | Drug: Mitomycin C 0.02% |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 19 < age < 60
- Refractory error stabled for at least one year
- No corneal pathology
- -3 < bilateral myopia and astigmatism < -5 with no difference more than 0.75 between 2 eyes
Key exclusion criteria (7 listed)
- Keratoconus
- Ectatic corneal disease
- Glaucoma
- Corneal dystrophy
- Lens changes affecting the visual acuity
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 |
|---|---|---|
| Mitomycin C 0.02% | Drug | Mitomycin c 0.02% |
| Placebo | Drug | Placebo |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2009.
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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 Phase 1 study testing Mitomycin C 0.02% in people with Myopia, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
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 22 Oct 2009. 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 Iran. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Mohammad Ali Javadi, MD (+982122585952, labbafi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 22 Oct 2009; AzTrials last refreshed its copy on 4 Nov 2026.