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Beatrice Cochener, Sabine Derrien; New medical device for chronic corneal ulcers healing. Invest. Ophthalmol. Vis. Sci. 2013;54(15):3904.
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© ARVO (1962-2015); The Authors (2016-present)
To report the cases of a series of patients suffering from chronic corneal ulcers resistant to conventional therapies and treated with a new ophthalmologic solution based on ReGeneraTing Agent technology (RGTA, Cacicol®). RGTA is a bioengineered analog of extracellular matrix components (heparan sulfates) which promote tissue regeneration. We report a series of 20 eyes treated with this innovative solution.
We conducted a monocenter opened prospective study. All of the 20 eyes had chronic corneal ulcers, except one who had a severe confluent keratitis. Ulcers were essentially chronic, and 8 patients had already received one or several amniotic membrane grafts or, without success. Two ulcers were due to basic chemical burns, one was associated with neurotrophic keratitis, and two were ulcers with herpetic kerititis. All patients were previously treated with classical lachrymal substitutes, some of them also with topical cyclosporine, corticoids, and/or A vitamin ocular ointment. The mean vertical and horizontal ulcer diameters were, respectively, 2.2 and 2.8 mm (range: 1-6.5 mm). Patients were treated with Cacicol® at a dose regimen of one drop daily every 2 or 3 days for one to two months depending on healing.
Complete healing was observed for 12 patients, i.e. a cure rate of 69 %. For other patients, 3 failures and one improvement without complete healing were reported. However a large variation was noted in the time for recovery of corneal integrity going from few days to few weeks. No correlation has been established between etiology, depth of ulcer and potential of regeneration. In case of severe ulcer and when a positive effect is observed at 1 month, a weekly drop is continued up to the complete healing.
Cacicol® appears as a new interesting healing eye drops in the context of severe chronic corneal ulcers resistant to conventional therapies. Its efficacy remains to be proven in randomized double-blind studies.
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