Contrast Sensitivity and Diabetic Macular Edema

NCT ID: NCT02217306

Last Updated: 2014-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

132 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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DIABETES MELLITUS DIABETIC RETINOPATHY MACULAR EDEMA

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Contrast Sensitivity

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Juarez de Mexico

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dulce Milagros Razo Blanco Hernández

MEDICAL RESEARCHER

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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DULCE MI RAZO BLANCO HERNANDEZ, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Juarez de Mexico

SURISADAI SERAFIN SOLIS, MSc

Role: STUDY_CHAIR

INSTITUTO POLITECNICO NACIONAL

LOURDES CA ORTEGA LUNA, MSc

Role: STUDY_CHAIR

INSTITUTO POLITECNICO NACIONAL

VIRGILIO LIMA GOMEZ, MD, MSc

Role: STUDY_DIRECTOR

Hospital Juarez de Mexico

Locations

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Hospital Juarez de Mexico

Mexico City, Mexico City, Mexico

Site Status

Countries

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Mexico

Other Identifiers

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HJM2295/14R

Identifier Type: -

Identifier Source: org_study_id

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