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NCT02217306 Clinical Trial

Contrast Sensitivity and Diabetic Macular Edema

DIABETES MELLITUS Clinical Trial

Official title:
Contrast Sensitivity and Diabetic Macular Edema

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02217306
Other study ID # HJM2295/14R
Secondary ID
Status Completed
Phase N/A
First received August 6, 2014
Last updated August 13, 2014
Start date January 2014
Est. completion date August 2014

Study information
Verified date August 2014
Source Hospital Juarez de Mexico
Contact n/a
Is FDA regulated No
Health authority Mexico: Federal Commission for Sanitary Risks Protection
Study type Observational

Clinical Trial Summary

Contrast sensitivity is a tool use to evaluate the visual function in all patients. It can be modified by different pathologies or by age. The purpose of this study is to identify the changes that could be in relationship with the course of diabetic retinopathy comparing with diabetic patient without retinopathy and in patients with diabetic macular edema so if it is a difference, research for therapeutic strategies to improve it in this patients.

Description:

Contrast sensitivity is defined as a subjective measurement, it is the ability to separate the image between figure and background, taking into account the minimum amount of light required; it is evaluated by the contrast threshold, which is the smallest amount of contrast needed to be able to see a target and solve their characteristics, would be his reciprocal value. Medina et al. curve reported in healthy Mexicans SC 5 to 80, where > 51 years have decreased compared to contrast sensitivity studies international; further that contrast sensitivity in older groups of 41 years is decreased high frequency.

Recruitment information / eligibility
Status Completed
Enrollment 132
Est. completion date August 2014
Est. primary completion date July 2014
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 70 Years
Eligibility Inclusion Criteria:

- DIABETIC PATIENTS

- 40-60 YEARS OLD

- ANY GENDER

- VISUAL ACUITY >0.25 IN DECIMAL EQUIVALENT,

Exclusion Criteria:

- PATIENTS WITH CATARACTS OR OTHER MACULOPATHY

- PATIENTS WITH CONTACT LENSES

- PATIENTS WITH REFRACTIVE ERROR >6.00DP

- PATIENTS WITH PREVIOUS OCULAR SURGERY

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

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 Contrast Sensitivity Diabetic patients who are attended at Ophthalmology service in a general hospital undergo to contrast sensitivity test evaluating all frequency by software with 5 spacial frequency (1.5, 3, 6, 12 and 18 cycle grade, Stereoptical Co 1996) in the Visual Basic program. up to 8 months No
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