Back to resultsAnterior Stromal Changes After PRK by Using Intraoperative Mitomicin C
Primary Purpose
Refractive Disorders
Status
Completed
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
Mitomycin C and Photorefractive keratectomy (PRK)
Sponsored by
About this trial
This is an interventional treatment trial for Refractive Disorders focused on measuring Mitomycin C, Corneal epithelium, Photorefractive keratectomy (PRK), Confocal microscope
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients cannot attend their appointments
- Residual, recurrent or active ocular disease
- Previous ocular surgery except PRK
- Autoimmune or connective tissue disease
- Pregnancy
Sites / Locations
- Asociación Para Evitar la Ceguera en Mëxico, Hospital "Luis Sánchez Bulnes".
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Topical mitomycin C on the corneal epithelium of patients undergoing photorefractive keratectomy (PRK)
Photorefractive keratectomy (PRK)without mitomycin C.
Outcomes
Primary Outcome Measures
A central scan of the anterior stroma was taken with the confocal microscope (Confoscan 4, Fortune Technologies, Italy)
Secondary Outcome Measures
Full Information
NCT ID
NCT00599950
First Posted
January 8, 2008
Last Updated
January 23, 2008
Sponsor
Asociación para Evitar la Ceguera en México
1. Study Identification
Unique Protocol Identification Number
NCT00599950
Brief Title
Anterior Stromal Changes After PRK by Using Intraoperative Mitomicin C
Official Title
Anterior Stromal Changes After PRK by Using Intraoperative Mitomicin C.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Asociación para Evitar la Ceguera en México
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Disorders
Keywords
Mitomycin C, Corneal epithelium, Photorefractive keratectomy (PRK), Confocal microscope
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Topical mitomycin C on the corneal epithelium of patients undergoing photorefractive keratectomy (PRK)
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Photorefractive keratectomy (PRK)without mitomycin C.
Intervention Type
Drug
Intervention Name(s)
Mitomycin C and Photorefractive keratectomy (PRK)
Intervention Description
Topical mitomycin C on the corneal epithelium of patients undergoing photorefractive keratectomy (PRK)
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Patients cannot attend their appointments
Residual, recurrent or active ocular disease
Previous ocular surgery except PRK
Autoimmune or connective tissue disease
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ramirez F Manuel, MD
Organizational Affiliation
Asociación para Evitar la Ceguera en México
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asociación Para Evitar la Ceguera en Mëxico, Hospital "Luis Sánchez Bulnes".
City
Mexico city
State/Province
Distrito Federal
ZIP/Postal Code
04030
Country
Mexico
12. IPD Sharing Statement
Citations:
PubMed Identifier
18046999
Citation
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.
Results Reference
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PubMed Identifier
17912939
Citation
Ghirlando 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.
Results Reference
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PubMed Identifier
17444091
Citation
Ying 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.
Results Reference
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Anterior Stromal Changes After PRK by Using Intraoperative Mitomicin C
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