1.1 Evidence on the efficacy of miniature lens system implantation for advanced age-related macular degeneration (AMD) shows that the procedure can improve both vision and quality of life in the short term. Data on short-term safety are available for limited numbers of patients. There is currently insufficient long-term evidence on both efficacy and safety. Therefore this procedure should only be used with special arrangements for clinical governance, consent and audit or research.
1.2 Clinicians wishing to do miniature lens system implantation for advanced AMD should take the following actions.
Inform the clinical governance leads in their trusts.
Ensure that patients understand the need to adapt to having a lens system implanted into 1 eye, the risk of early complications, and the uncertainties about long-term efficacy and safety. Clinicians should provide patients with clear information in an appropriate format. In addition, the use of NICE's information for the public is recommended.
1.3 Patient selection should include detailed assessment to predict the patient's ability to cope with the changes in vision after the operation. Extensive visual rehabilitation after the procedure may be required.
1.4 This procedure should only be done by experienced cataract surgeons with appropriate training in the implantation of miniature lens systems.
1.5 NICE encourages further research and publication on which patients may benefit and on safety and efficacy outcomes, particularly longer-term results. NICE may update the guidance on publication of further evidence.