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Association of Lutein, Zeaxanthin and Brilliant Blue in Chromovitrectomy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01627977
First Posted: June 26, 2012
Last Update Posted: March 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Rubens Belfort Jr., Federal University of São Paulo
June 22, 2012
June 26, 2012
March 16, 2016
October 2012
January 2014   (Final data collection date for primary outcome measure)
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
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 ]
    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 ]
    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 ]
    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 ]
    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
Intervention Model: Single Group Assignment
Masking: None (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
Badaro E, Furlani B, Prazeres J, Maia M, Lima AA, Souza-Martins D, Muccioli C, Lucatto LF, Belfort R Jr. Soluble lutein in combination with brilliant blue as a new dye for chromovitrectomy. Graefes Arch Clin Exp Ophthalmol. 2014 Jul;252(7):1071-8. doi: 10.1007/s00417-013-2539-5. Epub 2014 Jan 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
March 2014
January 2014   (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
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT01627977
LUT-RET
Yes
Not Provided
Plan to Share IPD: Yes
Plan Description: data published: Graefes Arch Clin Exp Ophthalmol. 2014 Jul;252(7):1071-8.
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
March 2016

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