Study Stopped
Undefined
Anterior Stromal Changes After PRK by Using Intraoperative Mitomicin C
1 other identifier
interventional
10
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jan 2007
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 8, 2008
CompletedFirst Posted
Study publicly available on registry
January 24, 2008
CompletedMay 30, 2024
May 1, 2024
Same day
January 8, 2008
May 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
A central scan of the anterior stroma was taken with the confocal microscope (Confoscan 4, Fortune Technologies, Italy)
Before surgery and 1 week, 1 month, 3 months, 6 months after surgery
Study Arms (2)
1
EXPERIMENTALTopical mitomycin C on the corneal epithelium of patients undergoing photorefractive keratectomy (PRK)
2
PLACEBO COMPARATORPhotorefractive keratectomy (PRK)without mitomycin C.
Interventions
Topical mitomycin C on the corneal epithelium of patients undergoing photorefractive keratectomy (PRK)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients cannot attend their appointments
- Residual, recurrent or active ocular disease
- Previous ocular surgery except PRK
- Autoimmune or connective tissue disease
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Asociación Para Evitar la Ceguera en Mëxico, Hospital "Luis Sánchez Bulnes".
Mexico City, Mexico City, 04030, Mexico
Related Publications (3)
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.
PMID: 18046999BACKGROUNDGhirlando 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.
PMID: 17912939BACKGROUNDYing 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.
PMID: 17444091BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ramirez F Manuel, MD
Asociación para Evitar la Ceguera en México
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 8, 2008
First Posted
January 24, 2008
Study Start
January 1, 2007
Primary Completion
January 1, 2007
Study Completion
November 1, 2007
Last Updated
May 30, 2024
Record last verified: 2024-05