Association of Lutein, Zeaxanthin and Brilliant Blue in Chromovitrectomy

Federal University of São Paulo

Status and phase: Completed; Phase 3

Conditions: Proliferative Diabetic Retinopathy; Macular Hole; Epiretinal Membrane

Treatments: Other: Dye of Lutein, Zeaxanthin and Brilliant Blue

Study type: Interventional

Funder types: Other

Identifiers

NCT01627977

LUT-RET

Details and patient eligibility

About

The aim of this study is to test the efficacy of the combination of dye Lutein, Zeaxanthin and brilliant blue to stain the internal limiting membrane as well as the epiretinal membranes during the Vitrectomy surgery.

Full description

Twenty five patients with epiretinal membrane, macular hole or proliferative diabetic retinopathy and indication of vitrectomy surgery will be selected to participate in this study.

Enrollment: 18 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients over 18 years, both gender
• Diagnosis of epiretinal membrane OR macular hole OR proliferative diabetic retinopathy
• Indication of surgical treatment for removal of the epiretinal membrane

Exclusion criteria

• Any history of eye disease
• glaucoma
• Eye infection affecting any structure provided eye

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Dye of Lutein/Zeaxanthin/Brilliant Blue

Experimental group

Description:

during the surgery will be evaluated if the dye is suitable for dyeing the internal limiting membrane as well as the epiretinal membrane

Treatment:

Other: Dye of Lutein, Zeaxanthin and Brilliant Blue