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Completed

NCT Number: NCT01627977

Association 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.

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Key information

Conditions

Epiretinal Membrane Eye Diseases Macular Hole Proliferative Diabetic Retinopathy Retinal Diseases Retinal Perforations

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Depto. of Ophthalmology - Hospital São Paulo - UNIFESP

São Paulo, 04023-062, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: lutein, zeaxanthin, brilliant blue

Primary outcomes

  1. 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

  1. 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)

  2. 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

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 26, 2012
Registry last updated
Mar 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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