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Association of Lutein, Zeaxanthin and Brilliant Blue in Chromovitrectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rubens Belfort Jr., Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01627977
First received: June 22, 2012
Last updated: March 15, 2016
Last verified: March 2016
  Purpose
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.

Condition Intervention Phase
Epiretinal Membrane
Macular Hole
Proliferative Diabetic Retinopathy
Other: Dye of Lutein, Zeaxanthin and Brilliant Blue
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Descriptive Study to Evaluate the Effectiveness of the Dye Compound of the Combination of Lutein, Zeaxanthin and Brilliant Blue in Chromovitrectomy

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Visibility of the membrane after injection of the dye [ Time Frame: during the surgery ] [ Designated as safety issue: No ]
    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:
  • Degree of impregnation of the dye [ Time Frame: during the surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: at the end of surgery ] [ Designated as safety issue: No ]
    the physician should evaluate the usefulness of the dye, according to the following scale: Bad, Fair, Good, Very Good


Enrollment: 18
Study Start Date: October 2012
Study Completion Date: March 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: lutein, zeaxanthin, brilliant blue

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

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01627977

Locations
Brazil
Depto. of Ophthalmology - Hospital São Paulo - UNIFESP
São Paulo, SP, Brazil, 04023-062
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Principal Investigator: Rubens Belfort, MD Federal University of São Paulo
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rubens Belfort Jr., Head Professor of the Departament of Ophthalmology, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01627977     History of Changes
Other Study ID Numbers: LUT-RET 
Study First Received: June 22, 2012
Last Updated: March 15, 2016
Health Authority: Brazil: National Health Surveillance Agency
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: data published: Graefes Arch Clin Exp Ophthalmol. 2014 Jul;252(7):1071-8.

Keywords provided by Federal University of São Paulo:
chromovitrectomy
epiretinal membrane

Additional relevant MeSH terms:
Diabetic Retinopathy
Epiretinal Membrane
Retinal Perforations
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on December 02, 2016