The evidence for corneal inlay implantation for correction of presbyopia is limited in quantity and quality and comes predominantly from case series; there is some evidence of efficacy in the short term. In addition, there are reports that adverse effects occur frequently. Therefore, this procedure should only be used with special arrangements for clinical governance, consent and audit or research.
Clinicians wishing to undertake corneal inlay implantation for correction of presbyopia should take the following actions:
Inform the clinical governance leads in their Trusts.
Ensure that patients understand that this is principally a cosmetic procedure that may reduce their need to wear spectacles or contact lenses. They should be made aware of other management options for presbyopia. They should be informed about the possible adverse events associated with the procedure and encouraged to balance these carefully against the expected benefits. Patients should be provided with clear written information. In addition, the use of NICE's information for the public is recommended.
Audit and review clinical outcomes of all patients having corneal inlay implantation for the correction of presbyopia (see section 3.1).
Both clinicians and manufacturers are encouraged to collect details of complications and long-term outcomes following corneal inlay implantation for correction of presbyopia, and to publish their findings. NICE may review the procedure on publication of further evidence.