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

March 26, 2013
July 10, 2013
January 2013
June 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01824862 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Reduction of Foveal Sensitivity in Eyes With Diabetic Macular Edema
Reduction of Foveal Sensitivity in Eyes With Diabetic Macular Oedema, With and Without Centre Involvement

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.

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.

Observational [Patient Registry]
Observational Model: Case Control
Time Perspective: Prospective
1 Day
Not Provided
Probability Sample

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

  • Diabetic Retinopathy
  • Clinically Significant Macular Edema
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
July 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
30 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Mexico
 
NCT01824862
HJM2021/11-B
Yes
Virgilio Lima Gomez, Hospital Juarez de Mexico
Hospital Juarez de Mexico
Not Provided
Study Chair: VIRGILIO LIMA GOMEZ, PhD Hospital Juarez de Mexico
Principal Investigator: Dulce M Razo Blanco Hernandez, MSc Hospital Juárez de México
Hospital Juarez de Mexico
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP