Efficacy of Dorzolamide as an Adjuvant After Focal Photocoagulation in Clinically Significant Macular Edema
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|ClinicalTrials.gov Identifier: NCT02227745|
Recruitment Status : Unknown
Verified March 2015 by Virgilio Lima Gomez, Hospital Juarez de Mexico.
Recruitment status was: Recruiting
First Posted : August 28, 2014
Last Update Posted : March 20, 2015
|Condition or disease||Intervention/treatment|
|Diabetic Retinopathy Diabetic Macular Edema||Drug: Dorzolamide hydrochloride (2%) Drug: Placebo Sodium hyaluronate 4mg|
Patients referred to ophthalmology for developing type 2 diabetes subspecialist ophthalmologist evaluate the macula them by biomicroscopy, pupillary dilation, to detect clinically significant macular edema. EMCS diagnosis is made according to ETDRS criteria, and patients who were requested to submit fluorescein angiography.
Patients presenting with focal leakage on angiography were scheduled focal photocoagulation; day focal photocoagulation is measured before the procedure Measurement of visual acuity, visual acuity, refraction Measuring contrast sensitivity Measurement of retinal sensitivity Measurement of Optical Coherence Tomography ophthalmoscopic review
Subsequently photocoagulation treatment was applied according to the guidelines of the ETDRS (1-50 number of shots, shot diameter of 100 microns and 120-180 mW power) and the patient was re-evaluated at 4 weeks, which will repeat the testing day photocoagulation.
The patient what the research project will be discussed, will be invited to participate, will be read and informed consent was explained, questions and concerns will be clarified during the study, and patients who agree to enter the study will be assigned so random treatment.
Patient 1 drop of topical drug in the treaty provided every 8 hours for 4 weeks eye is placed, the drug provided will be needed for 4 weeks, plus a control sheet dose delivery will be provided and shall be referenced again in April weeks later for evaluation:
After 4 weeks of topical treatment, evaluation from 8:00 to 11 pm will be the same from the first date
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Efficacy of Dorzolamide as an Adjuvant to Improve Visual Function After Focal Photocoagulation Treatment in Diabetic Patients With Clinically Significant Macular Edema|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||March 2015|
|Estimated Study Completion Date :||December 2015|
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
Drug: Dorzolamide hydrochloride (2%)
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
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
Drug: Placebo Sodium hyaluronate 4mg
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.
Other Name: Zonaker (0.5%)
- efficiency in visual function with dorzolamide after photocoagulation [ Time Frame: two months ]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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02227745
|Contact: Virgilio Lima Gómez, MD, PhD||015255477560 ext firstname.lastname@example.org|
|Contact: Dulce Mi Razo-Blanco Hernandez, M, PhD||015255477560 ext email@example.com|
|Hospital Juarez de Mexico||Recruiting|
|Mexico City, Mexico, 07760|
|Contact: VIRGILIO LIMA GOMEZ, MD, PhD 015255477560 ext 7503 firstname.lastname@example.org|
|Contact: DULCE MI RAZO-BLANCO HERNANDEZ, MD, PhD 015255477560 ext 7503 email@example.com|
|Principal Investigator: Virgilio Lima Gomez, Md, PhD|
|Sub-Investigator: Surisadai Serafín Solís|
|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|