---
title: Association of Lutein, Zeaxanthin and Brilliant Blue in Chromovitrectomy
nct_id: NCT01627977
overall_status: COMPLETED
phase: PHASE3
sponsor: Federal University of São Paulo
study_type: INTERVENTIONAL
primary_condition: Epiretinal Membrane
countries: Brazil
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01627977.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01627977"
ct_last_update_post_date: 2016-03-16
last_seen_at: "2026-05-12T07:14:12.584Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Association of Lutein, Zeaxanthin and Brilliant Blue in Chromovitrectomy

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

**NCT ID:** [NCT01627977](https://clinicaltrials.gov/study/NCT01627977)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 18
- **Lead Sponsor:** Federal University of São Paulo
- **Conditions:** Epiretinal Membrane, Macular Hole, Proliferative Diabetic Retinopathy
- **Start Date:** 2012-10
- **Completion Date:** 2014-03
- **CT.gov Last Update:** 2016-03-16

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 90 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Dye of Lutein/Zeaxanthin/Brilliant Blue** (EXPERIMENTAL) — during the surgery will be evaluated if the dye is suitable for dyeing the internal limiting membrane as well as the epiretinal membrane

## Interventions

- **Dye of Lutein, Zeaxanthin and Brilliant Blue** (OTHER) — dye composed of Lutein, Zeaxanthin and Brilliant Blue will be used during the vitrectomy surgery to dye the membranes

## Primary Outcomes

- **Visibility of the membrane after injection of the dye** _(time frame: 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 Outcomes

- **Degree of impregnation of the dye** _(time frame: during the surgery)_
- **Usefulness of the dye** _(time frame: at the end of surgery)_

## Locations (1)

- Depto. of Ophthalmology - Hospital São Paulo - UNIFESP, São Paulo, São Paulo, Brazil

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.depto. of ophthalmology - hospital são paulo - unifesp|são paulo|são paulo|brazil` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01627977.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01627977*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*