1.1 Evidence on the safety and efficacy of artificial iris implant insertion for acquired aniridia is limited in quantity and quality. Therefore, this procedure should only be used with special arrangements for clinical governance, consent, and audit or research. Find out what special arrangements mean on the NICE website.
1.2 Clinicians wishing to do artificial iris implant insertion for acquired aniridia should:
Inform the clinical governance leads in their NHS trusts.
Ensure that patients understand the procedure's safety and efficacy, as well as any uncertainties about these.
Audit and review clinical outcomes of all patients having the procedure. NICE has identified relevant audit criteria and developed an audit tool (which is for use at local discretion).
1.3 The procedure should only be done by ophthalmic surgeons with appropriate experience and training.
1.4 Research could include the use of observational data from cohort studies or high-quality case series. Studies should report details of patient selection and the type of implant used. Outcomes should include quality of life and other patient-reported outcomes.
1.5 NICE may update the guidance on publication of further evidence.