Efficacy of Dorzolamide as an Adjuvant After Focal Photocoagulation in Clinically Significant Macular Edema

NCT ID: NCT02227745

Last Updated: 2015-03-20

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-12-31

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

Detailed Description

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

Conditions

Diabetic Retinopathy; Diabetic Macular Edema

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Dorzolamide hydrochloride (2%)

Intervention Type: DRUG

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

Placebo Sodium hyaluronate 4mg

Intervention Type: DRUG

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.

Interventions

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

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Pio-bag (2%); Iop-Sox (2%); Zonaker (0.5%)

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Juarez de Mexico

OTHER_GOV

Sponsor Role: lead

Responsible Party

Virgilio Lima Gomez

PhMD, retinology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Virgilio Lima Gomez, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Juárez de México

Dulce Mi Razo-Blanco Hernandez, MD, PhD

Role: STUDY_CHAIR

Hospital Juarez de Mexico

Surisadai Serafín Solis

Role: STUDY_CHAIR

Instituto Politecnico Nacional

Locations

Hospital Juarez de Mexico

Mexico City, Mexico City, Mexico

Site Status: RECRUITING

Countries

Mexico

Central Contacts

Virgilio Lima Gómez, MD, PhD

Role: CONTACT

vlimag@eninfinitum.com

015255477560 ext. 7503

Dulce Mi Razo-Blanco Hernandez, M, PhD

Role: CONTACT

razoblanco.dulce@gmail.com

015255477560 ext. 7503

Facility Contacts

VIRGILIO LIMA GOMEZ, MD, PhD

Role: primary

vlimag@eninfinitum.com

015255477560 ext. 7503

DULCE MI RAZO-BLANCO HERNANDEZ, MD, PhD

Role: backup

razoblanco.dulce@gmail.com

015255477560 ext. 7503

Other Identifiers

HJM 2296/14-R

Identifier Type: -

Identifier Source: org_study_id