NCT02620644

Brief Summary

Neuroretinal damage in diabetes produces functional abnormalities such as the loss of chromatic discrimination,contrast sensitivity and dark adaptation. These alterations can be detected by means of electrophysiological studies in diabetic patients with diabetes duration of less than two years, i.e. before microvascular lesions can be detected in ophthalmologic examination. Neurodegeneration seems to be a generalized process that occurs throughout the macula and is not confined to local abnormalities, in the cases with visible signs of retinopathy. The debate is still open as to whether diabetic retinal neuropathy is the effect of vascular diabetic retinopathy or is primarily caused by direct neurologic damage from chronic hyperglycemia. The hypothesis that diabetes causes retinal neuro-pathy independent of retinopathy is intriguing and potentially links retinal neuropathy to other diabetic neuropathies. Neuroretinal degeneration initiates and/or activates several metabolic and signalling pathways which participates in the microangiopathic process as well as in the disruption of the blood-retinal barrier which is a crucial element in the pathogenesis of diabetic retinopathy. Retinal ganglion cells are the earliest cells affected and have the highest rate of apoptosis. However, an elevated rate of apoptosis has been also observed in the outer nuclear layer (photoreceptors) and in the retinal pigment epithelium (RPE). The use of spectral domain OCT (SD-OCT) makes it possible to measure the thickness of individual layers at higher resolution and indicates that the thinning of the inner retina in the macula is primarily due to loss of ganglion cells.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at below P25 for not_applicable diabetes

Timeline
Completed

Started Jan 2013

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, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 3, 2015

Completed
Last Updated

December 3, 2015

Status Verified

December 1, 2015

Enrollment Period

1.9 years

First QC Date

November 26, 2015

Last Update Submit

December 1, 2015

Conditions

Diabetes

Keywords

no retinopathy

Outcome Measures

Primary Outcomes (1)

  • Retinal Ganglion Cell Complex in microns by Optical Coherence Tomography measurements

    Baseline

Study Arms (2)

G1 Diabetics with no retinpathy

OTHER

Group 1 consists of diabetic patients free from diabetic retinopathy (45 eyes). OCT retinal GCC measurements.

Device: OCT Retinal GCC

G2 Non diabetics

OTHER

Group consists of non-diabetic subjects, free from any ocular pathology(21 eyes).OCT retinal GCC measurements.

Device: OCT Retinal GCC

Interventions

OCT Retinal GCCDEVICE

measuring of the retinal ganglion cell complex (GCC) thickness and the central foveal thickness (CFT) using the RTVue® SD-OCT (Optovue, Inc.)

G1 Diabetics with no retinpathyG2 Non diabetics

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetic patients free from diabetic retinopathy will be group 1
  • Non-diabetic subjects will be group 2.

You may not qualify if:

  • Diabetic patients with diabetic retinopathy
  • Patients having other ocular diseases as glaucoma or uveitis.
  • Eye with history of previous ocular surgeries, trauma or intraocular injections or photocoagulation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department Of Ophthalmology

Cairo, Cairo Governorate, 11221, Egypt

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Soheir Esmat, MD PhD

    Egypt:Cairo University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 26, 2015

First Posted

December 3, 2015

Study Start

January 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

December 3, 2015

Record last verified: 2015-12

Locations

EG(1)