Contrast Sensitivity and Diabetic Macular Edema

August 13, 2014 updated by: Dulce Milagros Razo Blanco Hernández, Hospital Juarez de Mexico
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.

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

132

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico City, Mexico, 07760
        • Hospital Juarez de Mexico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Diabetic patients attended at Ophthalmology service in a general hospital

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Contrast Sensitivity
Determine changes in contrast sensitivity frequences and visual function (visual acuity) after one month of treatment photocoagulation in macular edema

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Contrast Sensitivity
Time Frame: up to 8 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Juarez de Mexico

Investigators

  • Principal Investigator: DULCE MI RAZO BLANCO HERNANDEZ, MD, Hospital Juarez de Mexico
  • Study Chair: SURISADAI SERAFIN SOLIS, MSc, Instituto Politecnico Nacional
  • Study Chair: LOURDES CA ORTEGA LUNA, MSc, Instituto Politecnico Nacional
  • Study Director: VIRGILIO LIMA GOMEZ, MD, MSc, Hospital Juarez de Mexico

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

August 6, 2014

First Submitted That Met QC Criteria

August 13, 2014

First Posted (Estimate)

August 15, 2014

Study Record Updates

Last Update Posted (Estimate)

August 15, 2014

Last Update Submitted That Met QC Criteria

August 13, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HJM2295/14R

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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