Investigation of the retinal biocompatibility of acid violet for chromovitrectomy

Cardoso, Emmerson Badaró; Moraes-Filho, Milton N.; Rodrigues, Eduardo B.; Maia, Maurício; Penha, Fernando M.; Novais, Eduardo Amorim; Souza-Lima, Rodrigo A.; Meyer, Carsten H.; Farah, Michel Eid

doi:10.1007/s00417-013-2258-y

Cited by 16 publications

(15 citation statements)

References 32 publications

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“…A concentration of 0.05 mg/ml exposed to the inner retinal surface for 3 minutes resulted in a contrast sufficient for the removal of the ILM. A similar observation was reported by Cardoso et al 2013 [5] applying 0.3 ml of dye (concentration not mentioned) for 2 minutes to the inner retinal surface after removal of the posterior hyloid. The staining capacity was graded as satisfactory.…”

Section: Ilm-staining In Cadaveric Human Eyessupporting

confidence: 84%

“…On the other hand, the staining capacity and intensity of these dyes, which guide the surgeon to the ILM, are by far not ideal. Recently an interesting new dye, acid violet 17 (AV17) became commercially available after basic preclinical testing [5][6][7][8] and CE certification. AV17 (synonymous: Coomassie violet R200) is a triarylmethane dye (total formula: C 41 H 44 N 3 O 6 S 2 , molar weight: 761.92 g/mol, structural formula in l " Fig.…”

mentioning

confidence: 99%

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Acid Violet 17: a New Dye for Chromovitrectomy?

Gerding

2016

Klin Monatsbl Augenheilkd

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Section: Ilm-staining In Cadaveric Human Eyessupporting

confidence: 84%

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confidence: 99%

Acid Violet 17: a New Dye for Chromovitrectomy?

Gerding

2016

Klin Monatsbl Augenheilkd

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“…Neither BBG nor AV17 are thought to have any similar properties. Toxicity studies with AV17 have shown acceptable profiles in rabbit eyes at doses up to 0.50mg/ml and in an ex vivo bovine retinal model using AV17 mixed with deuterium oxide at doses of 0.125mg/ml [9,10]. At higher doses in the bovine model however evidence of inner retinal toxicity was seen histologically and on electrophysiology [9].…”

Section: Discussionmentioning

confidence: 99%

“…More recently Brilliant blue G (BBG) has been used by many surgeons and it is now marketed in heavier than water formulations with the addition of 4% polyethylene glycol (BBG-P)(ILM blue, DORC, the Netherlands) or deuterium oxide (Brilliant peel, Fluoron, Germany) [7,8]. The chemically similar aminotriarylmethane dye Acid violet 17 (AV17) has recently been introduced as an alternative to BBG and toxicity studies have shown acceptable profiles in an in vivo rabbit model and in an ex vivo bovine retina model [9,10]. It is marketed in a heavier than water preparation with 5% mannitol (AV17-M) (Alapurple, Alamedics, Germany).…”

Section: Introductionmentioning

confidence: 99%

An evaluation of two heavier-than-water internal limiting membrane-specific dyes during macular hole surgery

Steel

Karimi

White

2015

Graefes Arch Clin Exp Ophthalmol

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“…Indeed, in our article we noted that inner retinal toxicity had been found at doses exceeding 0.125 mg/ml in bovine eyes [2] and that the marketed preparation had a concentration of 1.5 mg/ml. We hypothesised that our methodology of a short (10 s) contact time and the added mannitol may explain the lack of toxicity we observed.…”

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confidence: 79%

Letter in response to letter: intraocular use of acid violet 17 at a concentration of 1.5 mg/ml is not safe

Steel

2017

Graefes Arch Clin Exp Ophthalmol

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Dear Editor, We thank Professor Gerding for his letter in response to our publication. We would like to point out that the study was performed and accepted for publication after the dye had been approved for human use and before it was withdrawn from the market. Our study was not connected with regulatory approval in any way. We investigated the dye for its staining properties and the induced cleavage plane of the internal limiting membrane (ILM) from the retina [1]. We also reported visual acuity outcomes which were no different from those found using Brilliant Blue G within the limitations of our experimental design. In the patients we treated, we did not observe any dye-related toxicity based on either vision, neurosensory retinal changes or retinal pigment epithelial alterations. Our ILM cleavage plane findings were also reassuring in this respect. We were concerned to hear of Professor Gerding's paper and, like all other responsible surgeons, stopped using the dye as soon as it was withdrawn from the market.We agree with all the points made regarding the preclinical studies. Indeed, in our article we noted that inner retinal toxicity had been found at doses exceeding 0.125 mg/ml in bovine eyes [2] and that the marketed preparation had a concentration of 1.5 mg/ml. We hypothesised that our methodology of a short (10 s) contact time and the added mannitol may explain the lack of toxicity we observed. Other possibilities-which we acknowledge are pure postulation-include a short light exposure time and low illumination levels during peeling. We also avoided repeat staining after ILM peeling ('double staining'). We were careful in the manuscript to explain our exact methodology of dye application, which avoids the jetting of dye onto the macular area and hole itself, and which as the correspondent observes may also have an effect on the occurrence of toxicity.We agree that a more vigorous approval process for dyes used during vitrectomy surgery should be considered by the regulatory bodies. This should include representative in vivo animal models using the concentrations and formulation as used in the marketed product. The tests should include the effects of light exposure during and after dye exposure, with direct dye-ILM contact without intervening vitreous for clinically realistic time periods. They should also evaluate the contact of dyes after ILM peeling on the exposed retinal nerve fibre layer, as double staining to check that all ILM has been peeled has been commonly described in surgical papers.

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Investigation of the retinal biocompatibility of acid violet for chromovitrectomy

Abstract: Acid violet may be safe for the retina at concentrations of 0.25 and 0.50 g/l after intravitreous injection, and may be used as a vital dye for staining the anterior capsule and the ILM.

Cited by 16 publications

References 32 publications

Acid Violet 17: a New Dye for Chromovitrectomy?

Acid Violet 17: a New Dye for Chromovitrectomy?

An evaluation of two heavier-than-water internal limiting membrane-specific dyes during macular hole surgery

Letter in response to letter: intraocular use of acid violet 17 at a concentration of 1.5 mg/ml is not safe

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