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A new dye based on anthocyanins from the acai fruit (Euterpe oleracea) for chromovitrectomy in humans: clinical trial results

  • Retinal Disorders
  • Published:
Graefe's Archive for Clinical and Experimental Ophthalmology Aims and scope Submit manuscript

Abstract

Purpose

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).

Methods

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.

Results

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.

Conclusion

The acai dye at a 25% concentration identified posterior hyaloids and ILMs during PPVs in humans. Dye toxicity was unlikely.

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Acknowledgments

Vision Institute (IPEPO) and Ophthalmos Pharmaceutical Industry.

Funding

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.

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Authors and Affiliations

  1. Vision Institute, Department of Ophthalmology, Federal University of São Paulo, 781, Pedro de Toledo Street, 2nd floor, São Paulo, 04039-032, Brazil

    Rafael R. Caiado, Cristiane Peris, Eduardo B. Rodrigues, Michel Eid Farah, André Maia, Octaviano Magalhães Jr, Eduardo Novais, Acácio Souza Lima-Filho & Mauricio Maia

  2. Ophthalmos Pharmaceutical Industry, São Paulo, Brazil

    Acácio Souza Lima-Filho

  3. Brazilian Institute of Fight Against Blindness, Assis/Presidente Prudente, São Paulo, Brazil

    Mauricio Maia

Authors
  1. Rafael R. Caiado
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  2. Cristiane Peris
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  3. Eduardo B. Rodrigues
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  4. Michel Eid Farah
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  5. André Maia
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  6. Octaviano Magalhães Jr
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  7. Eduardo Novais
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  8. Acácio Souza Lima-Filho
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  9. Mauricio Maia
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Corresponding author

Correspondence to Mauricio Maia.

Ethics declarations

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.

Ethical approval

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

Informed consent was obtained from all individual participants included in the study.

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Caiado, R.R., Peris, C., Rodrigues, E.B. et al. A new dye based on anthocyanins from the acai fruit (Euterpe oleracea) for chromovitrectomy in humans: clinical trial results. Graefes Arch Clin Exp Ophthalmol 257, 517–528 (2019). https://doi.org/10.1007/s00417-018-04204-y

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  • DOI: https://doi.org/10.1007/s00417-018-04204-y

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