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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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30 March 2015 |
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Main ID: |
NCT02227745 |
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Date of registration:
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26/08/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy of Dorzolamide as an Adjuvant After Focal Photocoagulation in Clinically Significant Macular Edema
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Scientific title:
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Efficacy of Dorzolamide as an Adjuvant to Improve Visual Function After Focal Photocoagulation Treatment in Diabetic Patients With Clinically Significant Macular Edema |
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Date of first enrolment:
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January 2014 |
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Target sample size:
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60 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02227745 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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Mexico
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Contacts
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Name:
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VIRGILIO LIMA GOMEZ, MD, PhD |
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Address:
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Telephone:
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015255477560 |
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Email:
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vlimag@eninfinitum.com |
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Affiliation:
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Name:
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Dulce Mi Razo-Blanco Hernandez, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital Juarez de Mexico |
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Name:
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Virgilio Lima Gomez, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital Juárez de México |
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Name:
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Virgilio Lima Gómez, MD, PhD |
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Address:
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Telephone:
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015255477560 |
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Email:
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vlimag@eninfinitum.com |
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Affiliation:
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Name:
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Surisadai Serafín Solis |
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Address:
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Telephone:
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Email:
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Affiliation:
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Instituto Politecnico Nacional |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- • Patients 40 to 70 years with diabetic retinopathy indistinct gender
- Clinically significant macular edema
- Focal Filtration in fluorescein angiography
- Means optical transparent
- Haemoglobin less than 7% (170)
- Best-corrected visual acuity = 20/200
- Signed Informed Consent
Exclusion Criteria:
- • Presence of other retinal or optic nerve diseases
- Presence of any other maculopathy
- Patient diagnosed with allergy to sulfa
- Patient with previous eye surgery four months
- Patients with prior application of focal photocoagulation
- Patients who use contact lenses 2 days before the application of
photocoagulation
- Presence of external eye disease, infection, inflammation at the time of
evaluation
- The presence of corneal disease present
- Refractive errors higher than 6.00 D (sphere) -3.00 D (cylinder)
- Study macular Fluorangiography Ischemia
- Thickness of the central field> 300 microns
Age minimum:
40 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diabetic Retinopathy
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Diabetic Macular Edema
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Intervention(s)
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Drug: Dorzolamide hydrochloride (2%)
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Drug: Placebo Sodium hyaluronate 4mg
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Primary Outcome(s)
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efficiency in visual function with dorzolamide after photocoagulation
[Time Frame: two months]
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Secondary ID(s)
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HJM 2296/14-R
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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