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

Diabetic Retinopathy Clinical Trial

Official title:

Efficacy of Dorzolamide as an Adjuvant to Improve Visual Function After Focal Photocoagulation Treatment in Diabetic Patients With Clinically Significant Macular Edema

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02227745
• Other study ID #: HJM 2296/14-R
• Status: Recruiting
• Phase: N/A
• First received: August 26, 2014
• Last updated: March 18, 2015
• Start date: January 2014
• Est. completion date: December 2015

Study information

• Verified date: March 2015
• Source: Hospital Juarez de Mexico
• Contact: Virgilio Lima Gómez, MD, PhD
• Phone: 015255477560
• Email: vlimag[@]eninfinitum.com
• Is FDA regulated: No
• Health authority: Mexico: Secretaria de Salud
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Diabetic Retinopathy
• Edema
• Macular Edema

Intervention

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 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.

Locations

Country	Name	City	State
Mexico	Hospital Juarez de Mexico	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Juarez de Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No