Association of Lutein, Zeaxanthin and Brilliant Blue in Chromovitrectomy

Phase 3

Completed

• Conditions: Epiretinal Membrane; Proliferative Diabetic Retinopathy; Macular Hole
• Interventions: Other: Dye of Lutein, Zeaxanthin and Brilliant Blue

• Registration Number: NCT01627977
• Lead Sponsor: Federal University of São Paulo

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2012-06-22
• Study First Submitted QC: 2012-06-25
• Study First Posted: 2012-06-26
• Study Start: 2012-10
• Primary Completion: 2014-01
• Study Completion: 2014-03
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-15
• Last Update Posted: 2016-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dye of Lutein/Zeaxanthin/Brilliant Blue	Dye of Lutein, Zeaxanthin and Brilliant Blue	during the surgery will be evaluated if the dye is suitable for dyeing the internal limiting membrane as well as the epiretinal membrane

Primary Outcome Measures

Name	Time	Method
Visibility of the membrane after injection of the dye	during the surgery	The visibility of the membrane after injection of the dye should be graduated by the physician as Bad, OR Fair, OR Good, OR Very Good

Secondary Outcome Measures

Name	Time	Method
Usefulness of the dye	at the end of surgery	the physician should evaluate the usefulness of the dye, according to the following scale: Bad, Fair, Good, Very Good
Degree of impregnation of the dye	during the surgery	The degree of impregnation of the membrane by the dye should be graduated according to the following scale:(0)not flushed; (1)stained weakly (light green); (2)moderately stained (medium green); (3)stained intensely (dark green)

Trial Locations

Locations (1)

Depto. of Ophthalmology - Hospital São Paulo - UNIFESP; 🇧🇷 São Paulo, SP, Brazil