A new dye based on anthocyanins from the acai fruit (Euterpe oleracea) for chromovitrectomy in humans: clinical trial results
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To test the applicability of the acai dye at a 25% concentration for identifying the posterior hyaloids and internal limiting membranes (ILMs) during pars plana vitrectomy (PPV) in human eyes with macular holes (MHs).
This study included 25 patients with chronic idiopathic MHs. The exclusion criteria included glaucoma, previous significant ocular conditions, and previous ocular surgeries except uncomplicated cataract. Ten surgeons performed 23-gauge four-port PPV, phacoemulsification, posterior hyaloid detachment, ILM peeling guided by dye staining, and perfluoropropane injection. The patients remained prone for 5 days postoperatively. The patients were evaluated postoperatively after 1, 30, and 180 days. The surgeons completed a questionnaire regarding the dye’s staining abilities.
The posterior hyaloids and ILMs stained purple in all eyes. The final best-corrected visual acuity improved significantly (p < 0.001) from preoperatively (1.37 ± 0.29) to 180 days postoperatively (1.05 ± 0.43). The MHs closed in 76% of eyes.
The acai dye at a 25% concentration identified posterior hyaloids and ILMs during PPVs in humans. Dye toxicity was unlikely.
KeywordsAcai dye Internal limiting membrane Pars plana vitrectomy Posterior hyaloid Toxicity
Vision Institute (IPEPO) and Ophthalmos Pharmaceutical Industry.
This study was funded by the Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq- 402718/2013-5), Brasília, Brazil, Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP – 2014/07686-8), São Paulo, Brazil.
Compliance with ethical standards
This prospective, interventional, non-randomized clinical study was registered at clinicaltrials.gov (NCT02691429). The consort flow diagram and checklist are available (Supplemental Digital Content 1). The Ethics Committee of the Federal University of São Paulo (Institutional Review Board number 466.833) and the National Brazilian Council of Research (CONEP authorization number 1.139.211) approved the study, which was conducted according to the Research Guidelines of the Association of Research in Vision Ophthalmology and the Declaration of Helsinki. To avoid BIAS during data interpretation, 10 surgeons performed 25 procedures following an aleatory protocol defined by the Ethics Committee of the Federal University of São Paulo. All patients provided informed consent regarding the benefits and risks of the surgical procedure and the new dye tested.
Conflict of interest
The authors declare that they have no conflict of interest.
All procedures performed in studies involving human participants were in accordance with the ethical standards of the UNIFESP and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
Informed consent was obtained from all individual participants included in the study.
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