Association of Lutein, Zeaxanthin and Brilliant Blue in Chromovitrectomy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Epiretinal Membrane, Macular Hole, Proliferative Diabetic Retinopathy

Intervention / Treatment
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* Other: Dye of Lutein, Zeaxanthin and Brilliant Blue


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dye of Lutein/Zeaxanthin/Brilliant Blue<br>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<br>* dye composed of Lutein, Zeaxanthin and Brilliant Blue will be used during the vitrectomy surgery to dye the membranes<br>* Other names: lutein, zeaxanthin, brilliant blue;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chromovitrectomy, epiretinal membrane