1.1 Current evidence on the safety and efficacy of insertion of hydrogel keratoprosthesis does not appear adequate for this procedure to be used without special arrangements for consent and for audit or research.
1.2 Clinicians wishing to undertake insertion of hydrogel keratoprosthesis should take the following actions.
Inform the clinical governance leads in their Trusts.
Ensure that patients understand the uncertainty about the procedure's safety and efficacy and provide them with clear written information. Use of the Institute's information for the public is recommended.
Audit and review clinical outcomes of all patients having insertion of hydrogel keratoprosthesis.
1.3 Publication of safety and efficacy outcomes will be useful in reducing the current uncertainty.
1.4 The manufacturer of the synthetic hydrogel cornea implant used in this procedure maintains a registry [link broken, Feb2012]. The Institute may review the procedure upon publication of further evidence.