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Efficacy and safety analysis of intraocular lutein-based dyes for vitreoretinal surgery in preclinical and clinical models

Session Details

Session Title: Quick Fire Free Paper 1

Session Date/Time: Thursday 11/09/2014 | 08:00-10:00

Paper Time: 09:30

Venue: Boulevard D

First Author: : J.Figueira PORTUGAL

Co Author(s): :    I. Laíns   D. Sousa Martins   J. Lencart   R. Belfort   M. Maia  

Abstract Details

Purpose:

To investigate the efficacy and safety of novel dyes composed of lutein in association with brilliant blue for staining the vitreous and the internal limiting membrane (ILM) during vitreoretinal surgery, in pre-clinical and clinical human models.

Setting:

Department of Ophthalmology, Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal.

Methods:

The preclinical efficacy of lutein-based dyes (Retidyne™ and Retidyne™ Plus) was tested in sixty human cadaveric eyes undergoing vitreoretinal surgery. The various dye solutions were in contact with intraocular membranes for 1 minute and then were removed by mechanical aspiration or membrane peeling, initiated and completed with intraocular forceps. The specimens were examined by light and electron transmission microscopy. These products were also tested in eighteen and twelve patients, using Retidyne™ and Retidyne Plus™, respectively, that underwent pars plana vitrectomy. A post-surgery questionnaire was completed and follow-up examinations were performed, including best corrected visual acuity (BCVA), optical coherence tomography, fluorescein angiogram, autofluorescence and visual fields.

Results:

In the preclinical study, contact between the lutein-based dyes and the retinal, lens, and vitreous surface resulted in orange staining of the vitreous and greenish blue staining of the ILM, which facilitated surgical steps in all eyes, with no histologic signs of toxicity. In the clinical study, we observed that both dyes were deposited on the posterior pole by gravity. Vigorous dye flushing into the vitreous cavity was unnecessary. Retidyne™ facilitated the ILM removal in all eyes, and Retidyne Plus™ stained both the ILM as well as the posterior hyaloid/vitreous base, by deposition onto the vitreous. BCVA improved in all eyes without clinical side effects toxicity signs on fundus images/visual fields. Histology showed effective removal of the ILM in all eyes.

Conclusions:

The natural dye solutions based on lutein combined with Brilliant Blue efficiently stained the vitreous and the ILM in human cadaveric eyes. In clinical use the new dyes were effective for intraoperative identification of the ILM, vitreous, and posterior hyaloid/vitreous base, and no dye-related adverse events were reported for any of the patients, confirming the excellent safety profile observed in previous rabbit model studies.

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