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June 1995

Keratoprosthesis With Biocolonizable Microporous Fluorocarbon HapticPreliminary Results in a 24-Patient Study

Author Affiliations

From the Department of Ophthalmology, Hôtel-Dieu de Paris (France) (Drs Legeais, Renard, Parel, and Pouliquen and Ms Savoldelli), and Ophthalmic Biophysics Center, Bascom Palmer Eye Institute, University of Miami (Fla) School of Medicine (Dr Parel). None of the authors have proprietary or financial interests in any of the devices or techniques described herein. Drs Legeais and Renard are named as inventors on a patent that, following French law, is solely and fully owned by France Chirurgie Industries, SA, Paris, France.

Arch Ophthalmol. 1995;113(6):757-763. doi:10.1001/archopht.1995.01100060083038

Background:  Most complications of a keratoprosthesis occur at the tissue-to-implant interface. The ideal prosthesis would eliminate this interface by having the tissue actually grow into the supporting material. We present a prospective clinical human study of a novel biocolonizable keratoprosthesis in 24 eyes of 24 patients.

Design:  To promote implant stability, the 9-mm—diameter haptic was fashioned using a custom-made microporous fluorocarbon with a 4-mm—diameter, 2.67-mm—long, central optic made of medical grade polymethylmethacrylate, giving a global visual field of 110° to 130°. Only bilaterally blind patients with untreatable corneal diseases were included in the study. The haptic was inserted into a lamellar pocket delaminated in the stroma, and the optic was positioned through a hole trephined in the central cornea.

Results:  The average follow-up was 15.7 months (range, 4 to 28 months). The host corneal fibroblasts penetrated and proliferated into the peripheral microporous fluorocarbon and provided anchorage between the cornea and prosthesis. Seventeen patients (70.8%) had visual acuity improvements. Mean corrected final visual acuity was 20/100 (range, 20/30 to 20/400). Five anatomic failures occurred in the first 6 months (three extrusions, one dislocation of the optic, and one endophthalmitis). We had one case (4.1%) of treatable glaucoma. We successfully removed four of five retroprosthetic membranes that had occurred. No retinal detachment occurred.

Conclusion:  The biocompatible inert microporous polymer did not eliminate all mechanical complications associated with a keratoprosthesis.