Diabetic Retinopathy Clinical Trial
Official title:
Applicability of the Acai Fruit (Euterpe Oleracea) Dye for Chromovitrectomy in Humans
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 São 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
São 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:
1. Physical and pre-anesthesia evaluations - to be performed by the Anesthesiology Team of
the São Paulo Hospital.
2. Complete Ophthalmological Examination - that will include:
1. Visual Acuity Measurements with best correction for both eyes.
2. Applaination Tonometry (Goldman Tonometer). For this, one drop of anesthetic
solution and one drop of fluorescein were instilled in the eye.
3. Biomicroscopy
4. Indirect binocular ophthalmoscopy: under mydriasis that will be obtained before
each procedure by topical application of tropicamide and phenylephrine.
5. Retinography and Angiofluoresceinography (with patient under mydriasis- except
when "opacidade de meios")
6. Optical Coherence Tomography (OCT) of the posterior segment (except when
"opacidade de meios")
7. Multifocal Electroretinogram (except when "opacidade de meios")
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03660384 -
Silicone Oil Versus Gas in PDR Patients Undergoing Vitrectomy
|
N/A | |
Completed |
NCT03660345 -
PPV With Internal Limiting Membrane Peeling for Treatment-Naïve DME
|
Phase 3 | |
Completed |
NCT03660371 -
ILM Peeling in PDR Patients Undergoing PPV for VH
|
N/A | |
Completed |
NCT04905459 -
ARDA Software for the Detection of mtmDR
|
||
Active, not recruiting |
NCT04271709 -
Manhattan Vision Screening and Follow-Up Study (NYC-SIGHT)
|
N/A | |
Recruiting |
NCT03713268 -
Intraoperative OCT Guidance of Intraocular Surgery II
|
||
Completed |
NCT05022615 -
Comparing 3 Imaging Systems
|
||
Completed |
NCT00385333 -
Metabolic Mapping to Measure Retinal Metabolism
|
Phase 2 | |
Recruiting |
NCT04101604 -
Biomarkers of Common Eye Diseases
|
||
Completed |
NCT03702374 -
Combined Antioxidant Therapy on Oxidative Stress, Mitochondrial Dysfunction Markers in Diabetic Retinopathy
|
Phase 3 | |
Completed |
NCT01908816 -
An Open-label Extended Clinical Protocol of Ranibizumab to Evaluate Safety and Efficacy in Rare VEGF Driven Ocular Diseases.
|
Phase 3 | |
Completed |
NCT04009980 -
Long-term Retinal Changes After Topical Citicoline Administration in Patients With Mild Signs of Diabetic Retinopathy in Type 1 Diabetes Mellitus.
|
N/A | |
Completed |
NCT02924311 -
Routine Clinical Practice for Use of Intravitreal Aflibercept Treatment in Patients With Diabetic Macular Edema
|
||
Not yet recruiting |
NCT06257082 -
Video-based Patient Education Intervention for Diabetic Eye Screening in Latinx Communities
|
N/A | |
Not yet recruiting |
NCT05452993 -
Screening for Diabetic Retinopathy in Pharmacies With Artificial Intelligence Enhanced Retinophotography
|
N/A | |
Withdrawn |
NCT02812030 -
Aflibercept for Retinopathy in the Real World
|
N/A | |
Completed |
NCT02391558 -
Clinical Evaluation of Noninvasive OCT Angiography Using a Zeiss OCT Prototype to Compare to Fluorescein Angiography
|
N/A | |
Active, not recruiting |
NCT02330042 -
OCT Biomarkers for Diabetic Retinopathy
|
||
Active, not recruiting |
NCT02353923 -
OcuStem Nutritional Supplement in Diabetic Patients With Mild to Moderate Non-proliferative Retinopathy
|
N/A | |
Completed |
NCT02390245 -
Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study
|
N/A |