The Chirila Keratoprosthesis: Phase I human clinical trial

Geoffrey J. Crawford; Celia R. Hicks; Qiaojun Lou; Sarojini Vijayasekaran; Donald Tan; Bridget Mulholland; Traian V. Chirila; Ian J. Constable

doi:10.1016/S0161-6420(02)00958-2

The Chirila Keratoprosthesis: Phase I human clinical trial

Geoffrey J. Crawford, Celia R. Hicks, Qiaojun Lou, Sarojini Vijayasekaran, Donald Tan, Bridget Mulholland, Traian V. Chirila, Ian J. Constable

Norwich Medical School

Research output: Contribution to journal › Article › peer-review

92 Citations (Scopus)

Abstract

Objective: To undertake a preliminary safety and performance evaluation of an artificial cornea, the Chirila Keratoprosthesis, in human patients.

Design. A prospective, interventional case series.

Participants: Fourteen consecutive patients with blindness of corneal origin not treatable by repeated standard penetrating keratoplasty.

Methods. Keratoprostheses were manufactured and implanted. The patients, all with preoperative visual acuity of light perception to count fingers (CF), were followed clinically in adherence to a protocol.

Main Outcome Measures: Safety (kerato prosthesis retention, incidence of serious complications) and performance (visual acuity, comfort, appearance).

Results: Ninety-three percent of kerato prostheses were retained to the date of reporting, up to 2.5 years. One keratoprosthesis (7%) was removed in a manner that restored the patient's preoperative condition. All but one patient maintained their preoperative level of visual acuity or improved on it, with most achieving their estimated full potential visual acuity, (range, count fingers - 20/20).

Conclusions: This keratoprosthesis is acceptably safe and has demonstrated an ability to restore vision in cases in which alternative management would have had a poor prognosis. More extensive trials are warranted. Ophthalmology 2002;109:883-889 (C) 2002 by the American Academy of Ophthalmology.

Original language	English
Pages (from-to)	883-889
Number of pages	7
Journal	Ophthalmology
Volume	109
Issue number	5
DOIs	https://doi.org/10.1016/S0161-6420(02)00958-2
Publication status	Published - May 2002
Event	Annual Meeting of the American Academy of Ophthalmology - Dallas, United States Duration: 22 Oct 2000 → 25 Oct 2000

Keywords

ARTIFICIAL CORNEA
RABBIT CORNEA
IMPLANTATION
SPONGES

Access to Document

10.1016/S0161-6420(02)00958-2

Cite this

@article{e8dd18504557451fa81dce488bc5f451,

title = "The Chirila Keratoprosthesis: Phase I human clinical trial",

abstract = "Objective: To undertake a preliminary safety and performance evaluation of an artificial cornea, the Chirila Keratoprosthesis, in human patients.Design. A prospective, interventional case series.Participants: Fourteen consecutive patients with blindness of corneal origin not treatable by repeated standard penetrating keratoplasty.Methods. Keratoprostheses were manufactured and implanted. The patients, all with preoperative visual acuity of light perception to count fingers (CF), were followed clinically in adherence to a protocol.Main Outcome Measures: Safety (kerato prosthesis retention, incidence of serious complications) and performance (visual acuity, comfort, appearance).Results: Ninety-three percent of kerato prostheses were retained to the date of reporting, up to 2.5 years. One keratoprosthesis (7%) was removed in a manner that restored the patient's preoperative condition. All but one patient maintained their preoperative level of visual acuity or improved on it, with most achieving their estimated full potential visual acuity, (range, count fingers - 20/20).Conclusions: This keratoprosthesis is acceptably safe and has demonstrated an ability to restore vision in cases in which alternative management would have had a poor prognosis. More extensive trials are warranted. Ophthalmology 2002;109:883-889 (C) 2002 by the American Academy of Ophthalmology.",

keywords = "ARTIFICIAL CORNEA, RABBIT CORNEA, IMPLANTATION, SPONGES",

author = "Crawford, {Geoffrey J.} and Hicks, {Celia R.} and Qiaojun Lou and Sarojini Vijayasekaran and Donald Tan and Bridget Mulholland and Chirila, {Traian V.} and Constable, {Ian J.}",

year = "2002",

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doi = "10.1016/S0161-6420(02)00958-2",

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journal = "Ophthalmology",

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note = "Annual Meeting of the American Academy of Ophthalmology ; Conference date: 22-10-2000 Through 25-10-2000",

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T1 - The Chirila Keratoprosthesis: Phase I human clinical trial

AU - Crawford, Geoffrey J.

AU - Hicks, Celia R.

AU - Lou, Qiaojun

AU - Vijayasekaran, Sarojini

AU - Tan, Donald

AU - Mulholland, Bridget

AU - Chirila, Traian V.

AU - Constable, Ian J.

PY - 2002/5

Y1 - 2002/5

N2 - Objective: To undertake a preliminary safety and performance evaluation of an artificial cornea, the Chirila Keratoprosthesis, in human patients.Design. A prospective, interventional case series.Participants: Fourteen consecutive patients with blindness of corneal origin not treatable by repeated standard penetrating keratoplasty.Methods. Keratoprostheses were manufactured and implanted. The patients, all with preoperative visual acuity of light perception to count fingers (CF), were followed clinically in adherence to a protocol.Main Outcome Measures: Safety (kerato prosthesis retention, incidence of serious complications) and performance (visual acuity, comfort, appearance).Results: Ninety-three percent of kerato prostheses were retained to the date of reporting, up to 2.5 years. One keratoprosthesis (7%) was removed in a manner that restored the patient's preoperative condition. All but one patient maintained their preoperative level of visual acuity or improved on it, with most achieving their estimated full potential visual acuity, (range, count fingers - 20/20).Conclusions: This keratoprosthesis is acceptably safe and has demonstrated an ability to restore vision in cases in which alternative management would have had a poor prognosis. More extensive trials are warranted. Ophthalmology 2002;109:883-889 (C) 2002 by the American Academy of Ophthalmology.

AB - Objective: To undertake a preliminary safety and performance evaluation of an artificial cornea, the Chirila Keratoprosthesis, in human patients.Design. A prospective, interventional case series.Participants: Fourteen consecutive patients with blindness of corneal origin not treatable by repeated standard penetrating keratoplasty.Methods. Keratoprostheses were manufactured and implanted. The patients, all with preoperative visual acuity of light perception to count fingers (CF), were followed clinically in adherence to a protocol.Main Outcome Measures: Safety (kerato prosthesis retention, incidence of serious complications) and performance (visual acuity, comfort, appearance).Results: Ninety-three percent of kerato prostheses were retained to the date of reporting, up to 2.5 years. One keratoprosthesis (7%) was removed in a manner that restored the patient's preoperative condition. All but one patient maintained their preoperative level of visual acuity or improved on it, with most achieving their estimated full potential visual acuity, (range, count fingers - 20/20).Conclusions: This keratoprosthesis is acceptably safe and has demonstrated an ability to restore vision in cases in which alternative management would have had a poor prognosis. More extensive trials are warranted. Ophthalmology 2002;109:883-889 (C) 2002 by the American Academy of Ophthalmology.

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KW - RABBIT CORNEA

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KW - SPONGES

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DO - 10.1016/S0161-6420(02)00958-2

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