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Association of Lutein, Zeaxanthin and Brilliant Blue in Chromovitrectomy

Primary Purpose

Epiretinal Membrane, Macular Hole, Proliferative Diabetic Retinopathy

Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Dye of Lutein, Zeaxanthin and Brilliant Blue
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Epiretinal Membrane focused on measuring chromovitrectomy, epiretinal membrane

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Depto. of Ophthalmology - Hospital São Paulo - UNIFESP

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dye of Lutein/Zeaxanthin/Brilliant Blue

Arm Description

during the surgery will be evaluated if the dye is suitable for dyeing the internal limiting membrane as well as the epiretinal membrane

Outcomes

Primary Outcome Measures

Visibility of the membrane after injection of the dye
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
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
the physician should evaluate the usefulness of the dye, according to the following scale: Bad, Fair, Good, Very Good

Full Information

First Posted
June 22, 2012
Last Updated
March 15, 2016
Sponsor
Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01627977
Brief Title
Association of Lutein, Zeaxanthin and Brilliant Blue in Chromovitrectomy
Official Title
A Descriptive Study to Evaluate the Effectiveness of the Dye Compound of the Combination of Lutein, Zeaxanthin and Brilliant Blue in Chromovitrectomy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epiretinal Membrane, Macular Hole, Proliferative Diabetic Retinopathy
Keywords
chromovitrectomy, epiretinal membrane

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dye of Lutein/Zeaxanthin/Brilliant Blue
Arm Type
Experimental
Arm Description
during the surgery will be evaluated if the dye is suitable for dyeing the internal limiting membrane as well as the epiretinal membrane
Intervention Type
Other
Intervention Name(s)
Dye of Lutein, Zeaxanthin and Brilliant Blue
Other Intervention Name(s)
lutein, zeaxanthin, brilliant blue
Intervention Description
dye composed of Lutein, Zeaxanthin and Brilliant Blue will be used during the vitrectomy surgery to dye the membranes
Primary Outcome Measure Information:
Title
Visibility of the membrane after injection of the dye
Description
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
Time Frame
during the surgery
Secondary Outcome Measure Information:
Title
Degree of impregnation of the dye
Description
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)
Time Frame
during the surgery
Title
Usefulness of the dye
Description
the physician should evaluate the usefulness of the dye, according to the following scale: Bad, Fair, Good, Very Good
Time Frame
at the end of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rubens Belfort, MD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Depto. of Ophthalmology - Hospital São Paulo - UNIFESP
City
São Paulo
State/Province
SP
ZIP/Postal Code
04023-062
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
data published: Graefes Arch Clin Exp Ophthalmol. 2014 Jul;252(7):1071-8.
Citations:
PubMed Identifier
24441951
Citation
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.
Results Reference
derived

Learn more about this trial

Association of Lutein, Zeaxanthin and Brilliant Blue in Chromovitrectomy

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