Assessment of Color Vision in Diabetic Patients

Assessment of Color Vision in Diabetic Patients Before and After the Use of Anti-vegf in the Treatment of Diabetic Macular Edema

Assessment of color vision in diabetic patients before and after the use of anti-vegf in the treatment of diabetic macular edema

Study Overview

• Status: Completed
• Conditions: Retinopathy, Diabetic
• Intervention / Treatment: Drug: lucentis

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Brazil
  • Goias
    • Goiânia, Goias, Brazil, 74110120
      • Instituto de Olhos de Goiania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Assessment of color vision in diabetic patients before and after the use of anti-vegf in the treatment of diabetic macular edema. Using the Ishirara's test to evaluate the possible visual loss.

Description

Inclusion Criteria:

• Having diabetic retinopathy with macular edema

Exclusion Criteria:

• Not having diabetic retinopathy with macular edema

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Anti-Vegf; Use intravitreous anti-vegf	Drug: lucentis; Use of lucentis and other anti-vegf in patients with diabetic retinopathy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of color vision in diabetic patients before and after the use of anti-vegf in the treatment of diabetic macular edema	Using the Ishihara's test to analise the possible loss of vision	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frame between the injections	Ant-Vegf	1 months

Collaborators and Investigators

• Sponsor: Instituto de Olhos de Goiania

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): October 30, 2017

Study Registration Dates

• First Submitted: November 7, 2017
• First Submitted That Met QC Criteria: November 16, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): November 17, 2017
• Last Update Submitted That Met QC Criteria: November 16, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Retinal Diseases; Diabetic Retinopathy; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Ranibizumab
• Other Study ID Numbers: TRABALHO PEDRO ARVO 2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No