Reduction of Foveal Sensitivity in Eyes With Diabetic Macular Edema

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Virgilio Lima Gomez, Hospital Juarez de Mexico
ClinicalTrials.gov Identifier:
NCT01824862
First received: March 26, 2013
Last updated: July 10, 2013
Last verified: July 2013
  Purpose

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.


Condition
Diabetic Retinopathy
Clinically Significant Macular Edema

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Reduction of Foveal Sensitivity in Eyes With Diabetic Macular Oedema, With and Without Centre Involvement

Resource links provided by NLM:


Further study details as provided by Hospital Juarez de Mexico:

Primary Outcome Measures:
  • foveal sensitivity [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Retinal thickness [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    measured in µm, according to the automatic value generated by the fast macular map of the optical coherence tomography


Enrollment: 60
Study Start Date: January 2013
Study Completion Date: July 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Detailed Description:

A non-experimental, comparative, prospective, cross-sectional study was conducted. 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.

Type 2 diabetic patients aged 30-85 years, from any gender, with central fixation, whose ocular media allowed obtaining an adequate quality Optical Coherence Tomography, who had CSME with focal angiographic pattern were included. Eyes with optic nerve or visual pathways diseases or any other ocular disease that decreased Best corrected visual acuity, were excluded. Diabetic patients without retinopathy who fulfilled the remaining selection criteria were evaluated as the reference group.

Sixty degrees colour fundus photographs were obtained in all the patients using a Visucam lite ocular fundus camera; in group 1 it was verified that no signs of diabetic retinopathy existed in the photographs; CSMO was diagnosed by biomicroscopy under mydryasis, according to the ETDRS criteria.

Retinal thickness was measured using Stratus optical coherence tomography (OCT), version 4.0.1 (Zeiss). The 6 mm fast macular map strategy was used, according to the following standardised operating procedure: mydriasis ≥6mm, inclusion of the spherical equivalent and anteroposterior axis, and optimisation of z axis and of polarisation; the photograph was taken with flash between 9:00 and 11:00, using an acquisition strategy for dark irises. The maps were obtained by the same investigator, independent from the one who evaluated the patients clinically; any deviation of the OCT line regarding the actual retina boundary was considered as a measurement error.

A 10° macular perimetry was obtained in all the patients, using a Humphrey field analyser model 750i (software version 4.1); the sixteen points evaluated were arbitrarily labelled. Retinal thickness within 3 mm from the centre of the fovea was measured in 9 fields, according to the fast macular map.

  Eligibility

Ages Eligible for Study:   30 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • optic nerve or visual pathways diseases or any other ocular disease that decreased Best corrected visual acuity
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01824862

Locations
Mexico
Virgilio Lima Gomez
Mexico, Distrito Federal, Mexico, 07760
Sponsors and Collaborators
Hospital Juarez de Mexico
Investigators
Study Chair: VIRGILIO LIMA GOMEZ, PhD Hospital Juarez de Mexico
Principal Investigator: Dulce M Razo Blanco Hernandez, MSc Hospital Juárez de México
  More Information

No publications provided

Responsible Party: Virgilio Lima Gomez, PhD, Hospital Juarez de Mexico
ClinicalTrials.gov Identifier: NCT01824862     History of Changes
Other Study ID Numbers: HJM2021/11-B
Study First Received: March 26, 2013
Last Updated: July 10, 2013
Health Authority: Mexico: Secretaria de Salud

Keywords provided by Hospital Juarez de Mexico:
clinically significant macular edema
foveal thickness
foveal sensitivity
perimetry
diabetic retinopathy

Additional relevant MeSH terms:
Macular Edema
Edema
Retinal Diseases
Diabetic Retinopathy
Macular Degeneration
Retinal Degeneration
Eye Diseases
Signs and Symptoms
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 18, 2014