Association of Lutein, Zeaxanthin and Brilliant Blue in Chromovitrectomy

Proliferative Diabetic Retinopathy Clinical Trial

Official title:

A Descriptive Study to Evaluate the Effectiveness of the Dye Compound of the Combination of Lutein, Zeaxanthin and Brilliant Blue in Chromovitrectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01627977
• Other study ID #: LUT-RET
• Status: Completed
• Phase: Phase 3
• First received: June 22, 2012
• Last updated: March 15, 2016
• Start date: October 2012
• Est. completion date: March 2014

Study information

• Verified date: March 2016
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Epiretinal Membrane
• Macular Hole
• Proliferative Diabetic Retinopathy

Intervention

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

Locations

Country	Name	City	State
Brazil	Depto. of Ophthalmology - Hospital São Paulo - UNIFESP	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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)	during the surgery	No
Secondary	Usefulness of the dye	the physician should evaluate the usefulness of the dye, according to the following scale: Bad, Fair, Good, Very Good	at the end of surgery	No