Efficacy of Dorzolamide as an Adjuvant After Focal Photocoagulation in Clinically Significant Macular Edema
1 other identifier
observational
60
1 country
1
Brief Summary
Photocoagulation is the standard treatment in the focal EMCS, disrupts vascular leakage and allows the pigment epithelium remove the intraretinal fluid is effective in reducing the incidence of visual loss but can reduce contrast sensitivity and retinal sensitivity, the characteristics of the function can be reduced such as setting (location and stability) are relevant to the quality of the patient's vision parameters, reading comprehension, especially the ability, duration of diabetic macular edema, could have a significant impact on survival and / or the functional reserve of the macular cells subjected to mechanical and toxic stress-induced edema. It seems that in the treatment of patients with EMCS, photoreceptor damage occurs as a recent phenomenon, and can precede neurodegeneration retinal photoreceptor loss, whereby visual function can be decreased. An adjunctive treatment as Dorzolamide facilitating effect helping resorption of intraretinal fluid through EPR and reduce adverse events that is the loss of contrast sensitivity and retinal sensitivity, response time of photocoagulation treatment could be reduced to the patient, because the rate of resorption of intraretinal fluid is facilitated and thus the duration of the response, also could reduce damage to vision caused by the inadequacies of the photoreceptors during the evolution of macular edema avoiding moderate visual loss, there by increasing the quality of life in terms of improving the quality of vision in diabetic patients. In addition to obtaining a specific adjuvant treatment with photocoagulation is helpful for focal edema in diabetic and a new level using dorzolamide in retina Dorzolamide as adjunctive therapy after focal photocoagulation is more effective than placebo in improving visual function in patients with diabetic macular edema
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 26, 2014
CompletedFirst Posted
Study publicly available on registry
August 28, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedMarch 20, 2015
March 1, 2015
1.2 years
August 26, 2014
March 18, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
efficiency in visual function with dorzolamide after photocoagulation
Effectiveness of dorzolamide (2%) in visual function (visual acuity, contrast sensitivity, retinal sensitivity) after 2 months of photocoagulation (treatment for focal Clinically Significant Macular Edema)
two months
Study Arms (2)
Dorzolamide hydrochloride (2%)
dorzolamide: diabetic patients with clinical significally macular edema with treatment photocoagulation dorzolamide (2%) application 1 drop every 8 hours for 4 weeks
Placebo Sodium hyaluronate4mg
placebo: diabetic patients with clinically significant macular edema(focal), with photocoagulation sodium hyaluronate (0.5%) application 1 drop every 8 hours for 4 weeks
Interventions
Subsequently photocoagulation treatment was applied according to the guidelines of the ETDRS, reevaluate the patient at 4 weeks. Patient 1 drop of topical drug in the treaty provided every 8 hours for 4 weeks eye and again 4 weeks after cited for evaluation will be placed
Intervention: Subsequently photocoagulation treatment was applied according to the guidelines of the ETDRS, reevaluate the patient at 4 weeks. Patient 1 drop of topical drug in the treaty provided every 8 hours for 4 weeks eye and again 4 weeks after cited for evaluation will be placed.
Eligibility Criteria
the accessible population are type 2 diabetic patients treated with focal photocoagulation in Hospital Juarez Mexico
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Juarez de Mexico
Mexico City, Mexico City, 07760, Mexico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Virgilio Lima Gomez, MD, PhD
Hospital Juárez de México
- STUDY CHAIR
Dulce Mi Razo-Blanco Hernandez, MD, PhD
Hospital Juarez de Mexico
- STUDY CHAIR
Surisadai Serafín Solis
Instituto Politecnico Nacional
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhMD, retinology
Study Record Dates
First Submitted
August 26, 2014
First Posted
August 28, 2014
Study Start
January 1, 2014
Primary Completion
March 1, 2015
Study Completion
December 1, 2015
Last Updated
March 20, 2015
Record last verified: 2015-03