Keratoprosthesis with biocolonizable microporous fluorocarbon haptic. Preliminary results in a 24-patient study.
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.


METHODS
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 degrees to 130 degrees. 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.


CONCLUSIONS
The biocompatible inert microporous polymer did not eliminate all mechanical complications associated with a keratoprosthesis.
Legeais
J M
JM
Department of Ophthalmology, Hôtel-Dieu de Paris, France.
Renard
G
G
Parel
J M
JM
Savoldelli
M
M
Pouliquen
Y
Y
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001672:Biocompatible Materials; D003315:Cornea / Q000502:physiology / Q000601:surgery*; D003316:Corneal Diseases / Q000503:physiopathology / Q000601:surgery*; D005260:Female; D005465:Fluorocarbon Polymers; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008768:Methylmethacrylates; D008875:Middle Aged; D011138:Polytetrafluoroethylene; D011183:Postoperative Complications; D011446:Prospective Studies; D019736:Prostheses and Implants; D014792:Visual Acuity / Q000502:physiology; D014794:Visual Fields / Q000502:physiology
D001672:Biocompatible Materials; D005465:Fluorocarbon Polymers; D008768:Methylmethacrylates; D011138:Polytetrafluoroethylene