NCT02217306

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

August 6, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 15, 2014

Completed
Last Updated

August 15, 2014

Status Verified

August 1, 2014

Enrollment Period

6 months

First QC Date

August 6, 2014

Last Update Submit

August 13, 2014

Conditions

DIABETES MELLITUSDIABETIC RETINOPATHYMACULAR EDEMA

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Contrast Sensitivity

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

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Diabetic patients attended at Ophthalmology service in a general hospital

You may qualify if:

  • DIABETIC PATIENTS
  • YEARS OLD
  • ANY GENDER
  • VISUAL ACUITY \>0.25 IN DECIMAL EQUIVALENT,

You may not qualify if:

  • PATIENTS WITH CATARACTS OR OTHER MACULOPATHY
  • PATIENTS WITH CONTACT LENSES
  • PATIENTS WITH REFRACTIVE ERROR \>6.00DP
  • PATIENTS WITH PREVIOUS OCULAR SURGERY

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Juarez de Mexico

Mexico City, Mexico City, 07760, Mexico

Location

MeSH Terms

Conditions

Diabetes MellitusDiabetic RetinopathyMacular Edema

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesRetinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsMacular DegenerationRetinal Degeneration

Study Officials

  • DULCE MI RAZO BLANCO HERNANDEZ, MD

    Hospital Juarez de Mexico

    PRINCIPAL INVESTIGATOR

  • SURISADAI SERAFIN SOLIS, MSc

    INSTITUTO POLITECNICO NACIONAL

    STUDY CHAIR

  • LOURDES CA ORTEGA LUNA, MSc

    INSTITUTO POLITECNICO NACIONAL

    STUDY CHAIR

  • VIRGILIO LIMA GOMEZ, MD, MSc

    Hospital Juarez de Mexico

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MEDICAL RESEARCHER

Study Record Dates

First Submitted

August 6, 2014

First Posted

August 15, 2014

Study Start

January 1, 2014

Primary Completion

July 1, 2014

Study Completion

August 1, 2014

Last Updated

August 15, 2014

Record last verified: 2014-08

Locations

ME(1)