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| Name | Class |
|---|---|
| Rafael R. Caiado | UNKNOWN |
| Casa de SaĂºde SĂ£o JosĂ© | OTHER |
| AcĂ¡cio Alves Souza Lima-Filho | UNKNOWN |
| Eduardo Novais |
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Our research group tested the toxicity of different dye concentrations extracted from the acai fruit using a rabbit model. The dye extracted from the acai fruit in concentrations of 10% and 25% was found to be safe for vitreoretinal surgery. This initial research represented the landmark research for testing this alternative vital dye in a clinical research in humans.
The aim of the present clinical trial in humans will be to test the applicability of the acai dye in the identification of the posterior hyaloid and ILM during vitreoretinal surgery in humans.
The purpose of the present clinical trial in humans will be to test the impregnation capacity of the acai dye (10 and 25% concentrations) in the identification of the posterior hyaloid and ILM during vitreoretinal surgery in humans.
Twenty-four patients that seek treatment at the Ophthalmology Department of The Federal University of SĂ£o Paulo will be selected for this study. Inclusion criteria will be patients diagnosed with epiretinal membrane, macular hole or diabetic retinopathy (with or without vitreal hemorrhages, and/or macular edema, and/or vitreomacular traction). All must be indicated for vitrectomy surgery for the removal of the epiretinal membrane and/or internal limiting membrane.
The present clinical trial was approved by the ethics committee of the Federal University of SĂ£o Paulo (CEP-UNIFESP). All patients will be invited to sign an Informed Consent Form before participating in the study.
Twenty-four different retina surgeons will operate one of the 24 selected patients, using the standard vitrectomy technique that employs 4 sclerotomies and a 23-gauge system with accessory illumination. All surgeries will be performed using the acai dye (Euterpe oleracea) in the following concentrations: 10% (n=12) or 25% (n=12).
Immediately after the procedure, each surgeon will be given an evaluation questionnaire to fill-in.
All patients will be submitted to the following routine pre-operatory evaluations:
Physical and pre-anesthesia evaluations - to be performed by the Anesthesiology Team of the SĂ£o Paulo Hospital.
Complete Ophthalmological Examination - that will include:
The vitrectomy surgery will be performed in all patients of this present study using the 23-gauge technique composed of 4 sclerectomies and vitrectomy without 23-gauge sutures.
During surgery, after vitreous removal, the dye extracted from the acai fruit will be slowly injected using a 23 or 25-gauge silicone cannula connected to a 5ml syringe. The objective of the slow injection of the dye is so that it will deposit over the posterior hyloid/peripheral vitreous due to gravity. At this moment, photographic documentation will be performed.
After the dislocation of the posterior hyloid, the removal of the peripheral vitreous and the excess dye, a MachemerTM (Volk, Germany) macula magnifying lens will be used to improve visualization for the removal of the ILM using an intraocular tweezers. If the ILM is not visible, a second injection with the dye will be performed.
At the end of the surgery, all patients will receive medical prescription of drops with antibiotic and corticoid association during 1 week after the procedure, following vitrectomy post-surgical routine.
A questionnaire with 6 questions (ANNEX 1) will be handed to each surgeon after the end of the surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| acai dye (Euterpe oleracea) 10% | Active Comparator | Twenty-four different retina surgeons will operate one of the 24 selected patients, using the standard vitrectomy technique that employs 4 sclerotomies and a 23-gauge system with accessory illumination. All surgeries will be performed using the acai dye (Euterpe oleracea) in the following concentrations: 10% (n=12) or 25% (n=12). Immediately after the procedure, each surgeon will be given an evaluation questionnaire to fill-in |
|
| acai dye (Euterpe oleracea) 25% | Active Comparator | Twenty-four different retina surgeons will operate one of the 24 selected patients, using the standard vitrectomy technique that employs 4 sclerotomies and a 23-gauge system with accessory illumination. All surgeries will be performed using the acai dye (Euterpe oleracea) in the following concentrations: 10% (n=12) or 25% (n=12). Immediately after the procedure, each surgeon will be given an evaluation questionnaire to fill-in |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acai dye 10% | Other | dye to be used during chromovitrectomy in humans |
|
| Measure | Description | Time Frame |
|---|---|---|
| ocular inflammation | signs of ocular inflammation | up to 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| intraocular pressure | increase of intraocular pressure | up to 30 days |
| complications of the posterior segment | macular edema | up to 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mauricio Maia | Federal University of SĂ£o Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept of Ophthalmology - UNIFESP/Hospital SĂ£o Paulo | SĂ£o Paulo | SĂ£o Paulo | 04023-062 | Brazil |
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| ID | Term |
|---|---|
| D019773 | Epiretinal Membrane |
| D012167 | Retinal Perforations |
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
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| UNKNOWN |
| Emmerson BadarĂ³ | UNKNOWN |
| André Maia | UNKNOWN |
| Rita Sinigaglia-Coimbra | UNKNOWN |
| Sung Eun S. Watanabe | UNKNOWN |
| Eduardo B. Rodrigues | UNKNOWN |
| Michel Eid Farah | UNKNOWN |
| Mauricio Maia | UNKNOWN |
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| D002318 |
| Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |