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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
Sponsor:
Information provided by (Responsible Party):
Virgilio Lima Gomez, Hospital Juarez de Mexico

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

Condition or disease Intervention/treatment
Diabetic Retinopathy Diabetic Macular Edema Drug: Dorzolamide hydrochloride (2%) Drug: Placebo Sodium hyaluronate 4mg

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


Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Group/Cohort Intervention/treatment
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

Other Names:
  • Pio-bag (2%)
  • Iop-Sox (2%)

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%)




Primary Outcome Measures :
  1. 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)



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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
the accessible population are type 2 diabetic patients treated with focal photocoagulation in Hospital Juarez Mexico
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

Information from the National Library of Medicine

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


Contacts
Contact: Virgilio Lima Gómez, MD, PhD 015255477560 ext 7503 vlimag@eninfinitum.com
Contact: Dulce Mi Razo-Blanco Hernandez, M, PhD 015255477560 ext 7503 razoblanco.dulce@gmail.com

Locations
Mexico
Hospital Juarez de Mexico Recruiting
Mexico City, Mexico, 07760
Contact: VIRGILIO LIMA GOMEZ, MD, PhD    015255477560 ext 7503    vlimag@eninfinitum.com   
Contact: DULCE MI RAZO-BLANCO HERNANDEZ, MD, PhD    015255477560 ext 7503    razoblanco.dulce@gmail.com   
Principal Investigator: Virgilio Lima Gomez, Md, PhD         
Sub-Investigator: Surisadai Serafín Solís         
Sponsors and Collaborators
Hospital Juarez de Mexico
Investigators
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

Responsible Party: Virgilio Lima Gomez, PhMD, retinology, Hospital Juarez de Mexico
ClinicalTrials.gov Identifier: NCT02227745     History of Changes
Other Study ID Numbers: HJM 2296/14-R
First Posted: August 28, 2014    Key Record Dates
Last Update Posted: March 20, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Edema
Macular Edema
Diabetic Retinopathy
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Hyaluronic Acid
Dorzolamide
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents
Antihypertensive Agents
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action