High MyopiaPhase 4BQ-01-07-ARVONCT00564213
Evaluation of the Prophylactic Use of Mitomycin C 0.02% to Inhibit Haze Formation After Photorefractive Keratectomy for High Myopia: 15 x 30 Seconds
A Phase 4 study testing PRK and a single intraoperative topical application of mitomycin C 0.02% for 15 seconds in people with High Myopia, run by Instituto de Olhos de Goiania.
Trial summary
To evaluate and compare the effect of the prophylactic use of two different exposure times of mitomycin C (MMC) 0.02% to inhibit haze formation after photorefractive keratectomy (PRK) for high myopia (> -7.0 D). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- High Myopia
- What is being tested?
- PRK and a single intraoperative topical application of mitomycin C 0.02% for 15 seconds
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Mar 2005to Sep 2007
- Phase
- Phase 4
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Myopia or compound myopic astigmatism
- Stable refractive error
- No associated eye disease
Who cannot join
- Diabetes,
- Autoimmune diseases
- Topographic abnormalities
About this study
To evaluate and compare the effect of the prophylactic use of two different exposure times of mitomycin C (MMC) 0.02% to inhibit haze formation after photorefractive keratectomy (PRK) for high myopia (> -7.0 D).
Methods: Forty six eyes of twenty three patients, 8 men and 15 women, with high myopia were included in this prospective study. Mean age at the time of PRK plus MMC was 31.7 years. Before PRK, the mean spherical equivalent was -8.50 D (range, -7.25 to -10.50 D). In each patient, one eye was randomly assigned to PRK and a single intraoperative topical application of mitomycin C 0.02% for 15 seconds (Group 1) and the fellow eye, for 30 seconds (Group 2).The inclusion criteria were high myopia, no central corneal opacity and inadequate corneal thickness to allow a safe Laser in situ keratomileusis procedure. Refraction, uncorrected visual acuity, best spectacle-corrected visual acuity (BSCVA), and slit-lamp evidence of corneal opacity (haze) were evaluated over 12 months
- Conditions
- High Myopia
- Being tested
- PRK and a single intraoperative topical application of mitomycin C 0.02% for 15 seconds
- Keywords
- Myopia, Mitomycin
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRK and a single intraoperative topical application of mitomycin C 0.02% for 15 secondsDrug
Mitomycin 0.02%
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | A single intraoperative topical application of mitomycin C 0.02% for 15 seconds Receives: Drug: PRK and a single intraoperative topical application of mitomycin C 0.02% for 15 seconds |
| 2 | Experimental | A single intraoperative topical application of mitomycin C 0.02% for 30 seconds Receives: Drug: PRK and a single intraoperative topical application of mitomycin C 0.02% for 15 seconds |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2007 (estimated)
- Study startMar 2005
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Olhos de Goiania
- Sponsor type
- University, hospital or other
- Investigators
- Belquiz A Nassaralla, Study chair, Instituto de Olhos de GOiânia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00564213
- Sponsor's protocol ID
- BQ -1-07-ARVO
- Acronym
- BQ-01-07-ARVO
- Status last verified
- Nov 2007
- First submitted
- 26 Nov 2007
- Last updated
- 26 Nov 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Prophylactic Use of Mitomycin C 0.02% to Inhibit Haze Formation After Photorefractive Keratectomy for High Myopia: 15 x 30 Seconds
- ClinicalTrials.gov ID
- NCT00564213
- Acronym / sponsor ID
- BQ-01-07-ARVO / BQ -1-07-ARVO
- Conditions
- High Myopia
- Keywords
- Myopia, Mitomycin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Instituto de Olhos de GoianiaUniversity, hospital or other
- Study start
- Mar 2005
- Study completion
- Sep 2007 (actual)
- First posted
- 27 Nov 2007 (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 and compare the effect of the prophylactic use of two different exposure times of mitomycin C (MMC) 0.02% to inhibit haze formation after photorefractive keratectomy (PRK) for high myopia (> -7.0 D).
Methods: Forty six eyes of twenty three patients, 8 men and 15 women, with high myopia were included in this prospective study. Mean age at the time of PRK plus MMC was 31.7 years. Before PRK, the mean spherical equivalent was -8.50 D (range, -7.25 to -10.50 D). In each patient, one eye was randomly assigned to PRK and a single intraoperative topical application of mitomycin C 0.02% for 15 seconds (Group 1) and the fellow eye, for 30 seconds (Group 2).The inclusion criteria were high myopia, no central corneal opacity and inadequate corneal thickness to allow a safe Laser in situ keratomileusis procedure. Refraction, uncorrected visual acuity, best spectacle-corrected visual acuity (BSCVA), and slit-lamp evidence of corneal opacity (haze) were evaluated over 12 months
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: PRK and a single intraoperative topical application of mitomycin C 0.02% for 15 secondsA single intraoperative topical application of mitomycin C 0.02% for 15 seconds |
| 2 | Experimental | Drug: PRK and a single intraoperative topical application of mitomycin C 0.02% for 15 secondsA single intraoperative topical application of mitomycin C 0.02% for 30 seconds |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Myopia or compound myopic astigmatism
- Stable refractive error
- No associated eye disease
Key exclusion criteria (3 listed)
- Diabetes,
- Autoimmune diseases
- Topographic abnormalities
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 and a single intraoperative topical application of mitomycin C 0.02% for 15 secondsMitomycin 0.02% | Drug | 1, 2 |
Primary outcome
Not reported in the source record.
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 26 Nov 2008.
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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.
Belquiz A Nassaralla study chair
Instituto de Olhos de GOiânia
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PRK and a single intraoperative topical application of mitomycin C 0.02% for 15 seconds in people with High Myopia, run by Instituto de Olhos de Goiania.
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 3 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 26 Nov 2008. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
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 26 Nov 2008.