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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01627977
Other study ID # LUT-RET
Secondary ID
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


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
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