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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rubens Belfort, MD | Federal University of São Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Depto. of Ophthalmology - Hospital São Paulo - UNIFESP | São Paulo | São Paulo | 04023-062 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24441951 | Derived | 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. |
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data published: Graefes Arch Clin Exp Ophthalmol. 2014 Jul;252(7):1071-8.
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| ID | Term |
|---|---|
| D019773 | Epiretinal Membrane |
| D012167 | Retinal Perforations |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D065146 | Zeaxanthins |
| C006796 | brilliant blue |
| D014975 | Lutein |
| ID | Term |
|---|---|
| D024341 | Xanthophylls |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 |
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|
the physician should evaluate the usefulness of the dye, according to the following scale: Bad, Fair, Good, Very Good |
| at the end of surgery |
| Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |