Association of Lutein, Zeaxanthin and Brilliant Blue in Chromovitrectomy

A Descriptive Study to Evaluate the Effectiveness of the Dye Compound of the Combination of Lutein, Zeaxanthin and Brilliant Blue in Chromovitrectomy

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01627977

Enrollment

Registered

2012-06-26

Start date

2012-10-31

Completion date

2014-03-31

Last updated

2016-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epiretinal Membrane, Macular Hole, Proliferative Diabetic Retinopathy

Keywords

chromovitrectomy, epiretinal membrane

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.

Interventions

OTHERDye of Lutein, Zeaxanthin and Brilliant Blue

dye composed of Lutein, Zeaxanthin and Brilliant Blue will be used during the vitrectomy surgery to dye the membranes

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)
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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026