Refractive DisordersPhase 4NCT00599950
Anterior Stromal Changes After PRK by Using Intraoperative Mitomicin C
A Phase 4 study testing Mitomycin C and Photorefractive keratectomy (PRK) in people with Refractive Disorders, run by Asociación para Evitar la Ceguera en México at 1 site in Mexico.
Trial summary
To evaluate the confocal microscopy changes in keratocyte density at the anterior stromal after Photorefractive keratectomy (PRK) surgery, using intraoperative mitomycin C(Mitolem, LEMERY, S.A. de C.V. Mexico D.F. Reg. 136M92 SSA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractive Disorders
- What is being tested?
- Mitomycin C and Photorefractive keratectomy (PRK)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteMexico
- Study dates
- Jan 2007to Nov 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ask for PRK surgery
- Patients with stable refraction in the last year
- Patients without systemic and ocular disease
- Patients with 500 microns in pachymetry normal topography
Who cannot join
- Patients cannot attend their appointments
- Residual, recurrent or active ocular disease
- Previous ocular surgery except PRK
- Autoimmune or connective tissue disease
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Asociación Para Evitar la Ceguera en Mëxico, Hospital "Luis Sánchez Bulnes".
Mexico City, Mexico City, 04030
About this study
Official title: Anterior Stromal Changes After PRK by Using Intraoperative Mitomicin C.
To evaluate the confocal microscopy changes in keratocyte density at the anterior stromal after Photorefractive keratectomy (PRK) surgery, using intraoperative mitomycin C(Mitolem, LEMERY, S.A. de C.V. Mexico D.F. Reg. 136M92 SSA).
Read the detailed description
10 eyes of 10 patients underwent PRK,using intraoperative mitomycin C (Mitolem, LEMERY, S.A. de C.V. Mexico D.F. Reg. 136M92 SSA), and 10 eyes for the same patients underwent PRK without intraoperative mitomycin C. A central scan of the total corneal thickness was taken with the confocal microscope (Confoscan 4, Fortune Technologies, Italy) after surgery, and 1 week, 1 month, 3 months, and 6 months after surgery. Corneal epithelial thickness and the Anterior stroma morphology were analyzed by using the NAVIS software V. 3.5.0 (NIDEK, Multi-Instrument Diagnostic System, Japan).
- Conditions
- Refractive Disorders
- Being tested
- Mitomycin C and Photorefractive keratectomy (PRK)
- Keywords
- Mitomycin C, Corneal epithelium, Photorefractive keratectomy (PRK), Confocal microscope
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitomycin C and Photorefractive keratectomy (PRK)Drug
Topical mitomycin C on the corneal epithelium of patients undergoing photorefractive keratectomy (PRK)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Topical mitomycin C on the corneal epithelium of patients undergoing photorefractive keratectomy (PRK) Receives: Drug: Mitomycin C and Photorefractive keratectomy (PRK) |
| 2 | Placebo comparator | Photorefractive keratectomy (PRK)without mitomycin C. Receives: Drug: Mitomycin C and Photorefractive keratectomy (PRK) |
What is being measured
The primary outcome is the main question the study is designed to answer.
A central scan of the anterior stroma was taken with the confocal microscope (Confoscan 4, Fortune Technologies, Italy)
Measured: Before surgery and 1 week, 1 month, 3 months, 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2008 (estimated)
- Study startJan 2007
- Primary completionJan 2007
- Study completionNov 2007
Why it stopped: Undefined
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Refractive DisordersStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asociación para Evitar la Ceguera en México
- Sponsor type
- University, hospital or other
- Investigators
- Ramirez F Manuel, MD, Principal investigator, Asociación para Evitar la Ceguera en México
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00599950
- Sponsor's protocol ID
- Cornea 4
- Status last verified
- May 2024
- First submitted
- 8 Jan 2008
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Midena E, Gambato C, Miotto S, Cortese M, Salvi R, Ghirlando A. Long-term effects on corneal keratocytes of mitomycin C during photorefractive keratectomy: a randomized contralateral eye confocal microscopy study. J Refract Surg. 2007 Nov;23(9 Suppl):S1011-4. doi: 10.3928/1081-597X-20071102-06.
PubMed 18046999Ghirlando A, Gambato C, Midena E. LASEK and photorefractive keratectomy for myopia: clinical and confocal microscopy comparison. J Refract Surg. 2007 Sep;23(7):694-702. doi: 10.3928/1081-597X-20070901-08.
PubMed 17912939Ying L, Xiao Z, Liuxueying Z, Yumei J. Clinical use of in vivo confocal microscopy through focusing in corneal refractive surgery. J Refract Surg. 2006 Nov;22(9 Suppl):S1041-6. doi: 10.3928/1081-597X-20061102-07.
PubMed 17444091
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterior Stromal Changes After PRK by Using Intraoperative Mitomicin C.
- ClinicalTrials.gov ID
- NCT00599950
- Acronym / sponsor ID
- Cornea 4
- Conditions
- Refractive Disorders
- Keywords
- Mitomycin C, Corneal epithelium, Photorefractive keratectomy (PRK), Confocal microscope
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Undefined
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Asociación para Evitar la Ceguera en MéxicoUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jan 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 24 Jan 2008 (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 confocal microscopy changes in keratocyte density at the anterior stromal after Photorefractive keratectomy (PRK) surgery, using intraoperative mitomycin C(Mitolem, LEMERY, S.A. de C.V. Mexico D.F. Reg. 136M92 SSA).
Detailed description
10 eyes of 10 patients underwent PRK,using intraoperative mitomycin C (Mitolem, LEMERY, S.A. de C.V. Mexico D.F. Reg. 136M92 SSA), and 10 eyes for the same patients underwent PRK without intraoperative mitomycin C. A central scan of the total corneal thickness was taken with the confocal microscope (Confoscan 4, Fortune Technologies, Italy) after surgery, and 1 week, 1 month, 3 months, and 6 months after surgery. Corneal epithelial thickness and the Anterior stroma morphology were analyzed by using the NAVIS software V. 3.5.0 (NIDEK, Multi-Instrument Diagnostic System, Japan).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Mitomycin C and Photorefractive keratectomy (PRK)Topical mitomycin C on the corneal epithelium of patients undergoing photorefractive keratectomy (PRK) |
| 2 | Placebo comparator | Drug: Mitomycin C and Photorefractive keratectomy (PRK)Photorefractive keratectomy (PRK)without mitomycin C. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients ask for PRK surgery
- Patients with stable refraction in the last year
- Patients without systemic and ocular disease
- Patients with 500 microns in pachymetry normal topography
Key exclusion criteria (5 listed)
- Patients cannot attend their appointments
- Residual, recurrent or active ocular disease
- Previous ocular surgery except PRK
- Autoimmune or connective tissue disease
- Pregnancy
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 and Photorefractive keratectomy (PRK)Topical mitomycin C on the corneal epithelium of patients undergoing photorefractive keratectomy (PRK) | Drug | 1, 2 |
Primary outcome
A central scan of the anterior stroma was taken with the confocal microscope (Confoscan 4, Fortune Technologies, Italy)
Time frame: Before surgery and 1 week, 1 month, 3 months, 6 months after surgery
Results and safety
The study was stopped early (reason given: Undefined). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Background: PubMed 18046999Midena E, Gambato C, Miotto S, Cortese M, Salvi R, Ghirlando A. Long-term effects on corneal keratocytes of mitomycin C during photorefractive keratectomy: a randomized contralateral eye confocal microscopy study. J Refract Surg. 2007 Nov;23(9 Suppl):S1011-4. doi: 10.3928/1081-597X-20071102-06.
- Background: PubMed 17912939Ghirlando A, Gambato C, Midena E. LASEK and photorefractive keratectomy for myopia: clinical and confocal microscopy comparison. J Refract Surg. 2007 Sep;23(7):694-702. doi: 10.3928/1081-597X-20070901-08.
- Background: PubMed 17444091Ying L, Xiao Z, Liuxueying Z, Yumei J. Clinical use of in vivo confocal microscopy through focusing in corneal refractive surgery. J Refract Surg. 2006 Nov;22(9 Suppl):S1041-6. doi: 10.3928/1081-597X-20061102-07.
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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.
Ramirez F Manuel, MD principal investigator
Asociación para Evitar la Ceguera en México
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mitomycin C and Photorefractive keratectomy (PRK) in people with Refractive Disorders, run by Asociación para Evitar la Ceguera en México at 1 site in Mexico.
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 5 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: stopped early, as of the sponsor's last update on 30 May 2024. 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 Mexico. 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 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 was stopped early (reason given: Undefined). Results are not available in the source record.
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?
A central scan of the anterior stroma was taken with the confocal microscope (Confoscan 4, Fortune Technologies, Italy) (time frame: Before surgery and 1 week, 1 month, 3 months, 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00599950, which also lists 3 linked publications.
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 30 May 2024; AzTrials last refreshed its copy on 1 Nov 2026.