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Association of Lutein, Zeaxanthin and Brilliant Blue in Chromovitrectomy

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.
 
ClinicalTrials.gov Identifier: NCT01627977
Recruitment Status : Completed
First Posted : June 26, 2012
Last Update Posted : March 16, 2016
Sponsor:
Information provided by (Responsible Party):
Rubens Belfort Jr., Federal University of São Paulo

Tracking Information
First Submitted Date  ICMJE June 22, 2012
First Posted Date  ICMJE June 26, 2012
Last Update Posted Date March 16, 2016
Study Start Date  ICMJE October 2012
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2012)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01627977 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2012)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2012)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Association of Lutein, Zeaxanthin and Brilliant Blue in Chromovitrectomy
Official Title  ICMJE A Descriptive Study to Evaluate the Effectiveness of the Dye Compound of the Combination of Lutein, Zeaxanthin and Brilliant Blue in Chromovitrectomy
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Epiretinal Membrane
  • Macular Hole
  • Proliferative Diabetic Retinopathy
Intervention  ICMJE 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
Study Arms  ICMJE 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 15, 2016)
18
Original Estimated Enrollment  ICMJE
 (submitted: June 25, 2012)
20
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01627977
Other Study ID Numbers  ICMJE LUT-RET
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: data published: Graefes Arch Clin Exp Ophthalmol. 2014 Jul;252(7):1071-8.
Responsible Party Rubens Belfort Jr., Federal University of São Paulo
Study Sponsor  ICMJE Federal University of São Paulo
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rubens Belfort, MD Federal University of São Paulo
PRS Account Federal University of São Paulo
Verification Date March 2016

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