Association of Lutein, Zeaxanthin and Brilliant Blue in Chromovitrectomy

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Federal University of São Paulo
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: November 1, 2012
Last verified: November 2012

June 22, 2012
November 1, 2012
October 2012
December 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01627977 on ClinicalTrials.gov Archive Site
  • 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
  • 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 acording 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 usufelness of the dye, according to the following scale: Bad, Fair, Good, Very Good
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 3
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Epiretinal Membrane
  • Macular Hole
  • Proliferative Diabetic Retinopathy
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
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
Intervention: Other: Dye of Lutein, Zeaxanthin and Brilliant Blue
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact: Mauricio Maia, MD 55-18-91137727 retina@femanet.com.br
Contact: Cristina Muccioli, MD 55-11-5572-6443 crissmucci@gmail.com
Brazil
 
NCT01627977
LUT-RET
Yes
Rubens Belfort Jr., Federal University of São Paulo
Federal University of São Paulo
Not Provided
Principal Investigator: Rubens Belfort, MD Federal University of São Paulo
Federal University of São Paulo
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP