Reduction of Foveal Sensitivity in Eyes With Diabetic Macular Edema

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Visual Function, Center Point Thickness and Macular Volume After Photocoagulation

NCT00906659

Diabetic Retinopathy Macular Edema

COMPLETED

Diabetic Macular Edema Severity at Diagnosis

NCT00886392

Diabetes Mellitus Diabetic Retinopathy Macular Edema

COMPLETED

Contrast Sensitivity and Diabetic Macular Edema

NCT02217306

DIABETES MELLITUS DIABETIC RETINOPATHY MACULAR EDEMA

COMPLETED

Describing Patient With DME, Their Patient Journey and Disease Progression

NCT05966753

Diabetic Macular Edema

COMPLETED

Phase 1 Study of VEGF Trap in Patients With Diabetic Macular Edema

NCT00320814

Diabetic Macular Edema

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetic Retinopathy Clinically Significant Macular Edema

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

eyes without diabetic retinopathy

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

No interventions assigned to this group

CSME without centre involvement

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

No interventions assigned to this group

CSME with centre involvement

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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