MyopiaNCT01504282
Mitomycin-c Application for PRK
A study testing mitomycin-C in people with Myopia, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
To evaluate the safety and efficacy of 5 seconds mitomycin-C (MMC) application during photorefractive keratectomy (PRK) for patients with low myopia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Myopia
- What is being tested?
- mitomycin-C
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteIran
- Study dates
- Start not givento not given
- 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 Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- The inclusion criteria was ablation depth less than 65 µm,
- a stable refractive error for at least 1 year
- corrected distance visual acuity (CDVA) of 0.1 LogMAR or better.
Who cannot join
- Patients with keratoconus suspect,
- excessive dry eyes,
- impaired wound healing processes,
- lenticular changes,
- corneal dystrophy,
- history of ocular surgery,
- anterior or posterior uveitis,
- glaucoma and retinal diseases were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mitomycin-c Application for Photorefractive Keratectomy
To evaluate the safety and efficacy of 5 seconds mitomycin-C (MMC) application during photorefractive keratectomy (PRK) for patients with low myopia.
- Conditions
- Myopia
- Being tested
- mitomycin-C, 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-CDrug
PlaceboDrug
balanced salt solution (BSS)
| Study group | Role | What they receive |
|---|---|---|
| MMC group | Active comparator | One eye of each patient was randomly assigned to receive intraoperative topical 0.02% MMC for 5 seconds. Receives: Drug: mitomycin-C |
| BSS group | Placebo comparator | One eye of each patient was randomly assigned to receive balanced salt solution (BSS) with the same manner. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central corneal endothelial cell density (ECD) 6 months after the PRK
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2012 (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.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01504282
- Sponsor's protocol ID
- 8901
- Status last verified
- Jun 2010
- First submitted
- 4 Jan 2012
- Last updated
- 5 Jan 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitomycin-c Application for Photorefractive Keratectomy
- ClinicalTrials.gov ID
- NCT01504282
- Acronym / sponsor ID
- 8901
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- First posted
- 5 Jan 2012 (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.
To evaluate the safety and efficacy of 5 seconds mitomycin-C (MMC) application during photorefractive keratectomy (PRK) for patients with low myopia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MMC group | Active comparator | Drug: mitomycin-COne eye of each patient was randomly assigned to receive intraoperative topical 0.02% MMC for 5 seconds. |
| BSS group | Placebo comparator | Drug: PlaceboOne eye of each patient was randomly assigned to receive balanced salt solution (BSS) with the same manner. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- The inclusion criteria was ablation depth less than 65 µm,
- a stable refractive error for at least 1 year
- corrected distance visual acuity (CDVA) of 0.1 LogMAR or better.
Key exclusion criteria (8 listed)
- Patients with keratoconus suspect,
- excessive dry eyes,
- impaired wound healing processes,
- lenticular changes,
- corneal dystrophy,
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 | Drug | MMC group |
| Placebobalanced salt solution (BSS) | Drug | BSS group |
Primary outcome
Central corneal endothelial cell density (ECD) 6 months after the PRK
Time frame: 6 months
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 5 Jan 2012.
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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 mitomycin-C 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 3 inclusion and 8 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 5 Jan 2012. 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.
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?
Central corneal endothelial cell density (ECD) 6 months after the PRK (time frame: 6 months). 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 5 Jan 2012.