Association of Lutein, Zeaxanthin and Brilliant Blue in Chromovitrectomy

March 15, 2016 updated by: Rubens Belfort Jr., Federal University of São Paulo

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 04023-062
        • Depto. of Ophthalmology - Hospital São Paulo - UNIFESP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Dye of Lutein/Zeaxanthin/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
Other: Dye 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
Other Names:
  • lutein, zeaxanthin, brilliant blue

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
during the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of impregnation of the dye
Time Frame: 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)
during the surgery
Usefulness of the dye
Time Frame: at the end of surgery
the physician should evaluate the usefulness of the dye, according to the following scale: Bad, Fair, Good, Very Good
at the end of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (ACTUAL)

January 1, 2014

Study Completion (ACTUAL)

March 1, 2014

Study Registration Dates

First Submitted

June 22, 2012

First Submitted That Met QC Criteria

June 25, 2012

First Posted (ESTIMATE)

June 26, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

March 16, 2016

Last Update Submitted That Met QC Criteria

March 15, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LUT-RET

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

data published: Graefes Arch Clin Exp Ophthalmol. 2014 Jul;252(7):1071-8.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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3
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