Reduction of Foveal Sensitivity in Eyes With Diabetic Macular Edema

NCT01824862 | Completed DMC

• 1 other identifier: HJM2021/11-B
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Clinically significant macular edema (CSME) is a thickening of the macula associated with the risk of visual loss, which increases its centre is involved. Functional evaluation of the macula relies on best corrected visual acuity; however, neural dysfunction in diabetic eyes appears before retinal thickening and visual loss. Retinal sensitivity decreases in eyes with CSME, but it is unknown whether it differs between eyes with and without centre thickening. Aim: To compare the reduction of foveal sensitivity in eyes with CSME, with and without centre thickening.

Conditions

Diabetic Retinopathy; Clinically Significant Macular Edema

Keywords

clinically significant macular edema; foveal thickness; foveal sensitivity; perimetry; diabetic retinopathy

Outcome Measures

Primary Outcomes (1)

• foveal sensitivity

  the ability of the fovea to perceive a light stimulus in 16 central points, which is measured in dB with a 10 degree central macular perimetry

  1 day

Secondary Outcomes (1)

• Retinal thickness

  1 day

Study Arms (3)

eyes without diabetic retinopathy

eyes of patients with diabetes mellitus type 2 that does not have retinopathy

CSME without centre involvement

eyes with CSME without thickening in the 500 µm adjacent to the centre of the macula

CSME with centre involvement

eyes with CSME with thickening in the 500 µm adjacent to the centre of the macula

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

target population were type 2 diabetics, from Mexico City and its metropolitan area, and available population were type 2 diabetics who attended an Ophthalmology service from a general hospital in Mexico City, from September 2011 to May 2012

You may qualify if:

• Type 2 diabetic patients
• aged 30-85 years
• from any gender
• with central fixation
• ocular media allowed obtaining an adequate quality Optical coherence tomography
• CSME with focal angiographic pattern

You may not qualify if:

• optic nerve or visual pathways diseases or any other ocular disease that decreased Best corrected visual acuity

Sponsors & Collaborators

• Hospital Juarez de Mexico: lead

Study Sites (1)

Virgilio Lima Gomez

Mexico City, Mexico City, 07760, Mexico

Location

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• VIRGILIO LIMA GOMEZ, PhD

  Hospital Juarez de Mexico

  STUDY CHAIR

• Dulce M Razo Blanco Hernandez, MSc

  Hospital Juárez de México

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: March 26, 2013
• First Posted: April 5, 2013
• Study Start: January 1, 2013
• Primary Completion: June 1, 2013
• Study Completion: July 1, 2013
• Last Updated: July 11, 2013

Record last verified: 2013-07

Locations

ME (1)