Evaluation of Blood-retinal Barrier Functional Alterations by Optical Coherence Tomography (CNTM025A OCT)

Association for Innovation and Biomedical Research on Light and Image

Status: Completed

Conditions: Diabetic Retinopathy

Study type: Observational

Funder types: Other

Identifiers

NCT01220804

PTDC/SAU-BEB/103151/2008

Details and patient eligibility

About

The purpose of this study is to identify alterations of the blood-retinal barrier (BRB) in diabetic retinas using a novel non-invasive approach based on the Fourier domain high-definition optical coherence tomograph (OCT).

Full description

Type 2 diabetic patients with nonproliferative diabetic retinopathy (NPDR) (study population) and healthy volunteers (control population).

Inclusion Criteria:

Age over 18 years; type-2 diabetes; NPDR levels 10, 20 and 35/47 (ETDRS severity scale); and an area of retinal leakage of at least 25% of the RLA map (macular area).

Exclusion Criteria:

Presence of media opacity; vitreous syneresis or posterior vitreous detachment, and; previous photocoagulation treatments or any type of intraocular surgery or intravitreal medications; and other retinal pathologies.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age over 18 years; type-2 diabetes; NPDR levels 10, 20 and 35/47 (ETDRS severity scale), and area of retinal leakage of at least 25% of the RLA map (macular area).

Exclusion criteria

• Presence of media opacity; vitreous syneresis or posterior vitreous detachment, and; previous photocoagulation treatments or any type of intraocular surgery or intravitreal medications.

Trial design

30 participants in 2 patient groups

NPDR

Description:

Type 2 diabetic patients with nonproliferative diabetic retinopathy (NPDR)

Control Population

Description:

Healthy volunteers