Association of Lutein, Zeaxanthin and Brilliant Blue in Chromovitrectomy

NCT01627977 | Completed Phase 3 DMC

• 1 other identifier: LUT-RET
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Epiretinal Membrane; Macular Hole; Proliferative Diabetic Retinopathy

Keywords

chromovitrectomy; epiretinal membrane

Outcome Measures

Primary Outcomes (1)

• 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

  during the surgery

Secondary Outcomes (2)

• Degree of impregnation of the dye

  during the surgery

• Usefulness of the dye

  at the end of surgery

Study Arms (1)

Dye of Lutein/Zeaxanthin/Brilliant Blue

EXPERIMENTAL

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

Interventions

Dye of Lutein, Zeaxanthin and Brilliant Blue OTHER

dye composed of Lutein, Zeaxanthin and Brilliant Blue will be used during the vitrectomy surgery to dye the membranes

Also known as: lutein, zeaxanthin, brilliant blue

Dye of Lutein/Zeaxanthin/Brilliant Blue

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Any history of eye disease
• glaucoma
• Eye infection affecting any structure provided eye

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Depto. of Ophthalmology - Hospital São Paulo - UNIFESP

São Paulo, São Paulo, 04023-062, Brazil

Location

Related Publications (1)

• 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.

  PMID: 24441951 DERIVED

MeSH Terms

Conditions

Epiretinal Membrane; Retinal Perforations

Interventions

Zeaxanthins; brilliant blue; Lutein

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Xanthophylls; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Study Officials

• Rubens Belfort, MD

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Professor of the Departament of Ophthalmology

Study Record Dates

• First Submitted: June 22, 2012
• First Posted: June 26, 2012
• Study Start: October 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: March 1, 2014
• Last Updated: March 16, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)