Topical treatment with a new matrix therapy agent (RGTA) for the treatment of corneal neurotrophic ulcers.

PURPOSE: Neurotrophic keratopathy is a degenerative disease of the corneal epithelium resulting from impaired corneal innervation, possibly leading to perforation. We aimed to assess the efficacy and tolerance of a new matrix therapy agent (RGTA, Cacicol20), mimicking heparan sulfates, for the management of neurotrophic keratopathy.
METHODS: We carried out an uncontrolled, prospective, single-center clinical study on 11 patients (11 eyes) with severe corneal neurotrophic ulcers, despite the use of preservative-free artificial tears, for 15 days. Patients were treated with RGTA eye drops, instilled at a dosage of one drop in the morning, on alternate days. Evolution and follow-up during treatment were evaluated by slit-lamp examination, photography, fluorescein-dye testing, tests of corneal sensitivity, and best corrected visual acuity. The main outcome measures for each patient were healing of the corneal surface and best corrected visual acuity before and after RGTA therapy.
RESULTS: Eight patients displayed complete corneal healing after a mean period of 8.7 weeks (range; 1 to 22 weeks). Mean ulcer area decreased significantly, from 11.12% to 6.37% (P = 0.048) in the first week, and to 1.56% (P = 0.005) at 1 month. Treatment failure was observed in three cases, requiring amniotic membrane transplantation in two patients and penetrating keratoplasty in one patient. At the end of the study, none of the patients displayed significant improvement in visual acuity. There were no systemic or local side effects of treatment.
CONCLUSIONS: RGTA seems to be a potentially useful, alternative, noninvasive therapeutic approach in neurotrophic keratopathy management. However, randomized studies are necessary.