The National Institute for Clinical Excellence is examining macular translocation for age-related macular degeneration and will publish guidance on its safety and efficacy to the NHS in England and Wales. The Institute's Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisors, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about macular translocation for age-related macular degeneration.

This document has been prepared for public consultation. It summarises the procedure and sets out the provisional recommendation made by the Advisory Committee.

Note that this document is not the Institute's formal guidance on this procedure. The recommendations are provisional and may change after consultation.

The process that the Institute will follow after the consultation period ends is as follows.

• The Advisory Committee will meet again to consider the original evidence and its provisional recommendations in the light of the comments received during consultation.
• The Advisory Committee will then prepare the Final Interventional Procedure Document (FIPD) and submit it to the Institute.
• The FIPD may be used as the basis for the Institute's guidance on the use of the procedure in the NHS in England and Wales.

For further details, see the Interim Guide to the Interventional Procedures Programme, which is available from the Institute's website (www.nice.org.uk/ip).

Closing date for comments: 23 December 2003

Target date for publication of guidance: March 2004

Note that this document is not the Institute's guidance on this procedure. The recommendations are provisional and may change after consultation.

Current evidence of the safety and efficacy of macular translocation does not appear adequate for this procedure to be used without special arrangements for consent and for audit or research. Clinicians wishing to undertake macular translocation should inform the clinical governance leads in their Trusts. They should ensure that patients offered it understand the uncertainty about the procedure's safety and efficacy and should provide them with clear written information. Use of the Institute's Information for the Public is recommended. Clinicians should ensure that appropriate arrangements are in place for audit and research. Publication of safety and efficacy outcomes will be useful in reducing the current uncertainty. NICE is not undertaking further investigation at present.

Age-related macular degeneration comprises a group of conditions that affect central vision, and can lead to irreversible blindness. The prevalence of macular degeneration increases with age.

Ninety percent of people with age-related macular degeneration (AMD) have dry (atrophic) macular degeneration, characterised by thinning of the macular retina. The other 10% have wet (exudative or neovascular) macular degeneration, characterised by the growth of abnormal new blood vessels in the choroid layer underneath the retina. These new vessels can leak fluid and cause scarring, which can threaten vision. The vessels can be classified using fluoroscein angiography into 'classic' if they can be seen clearly and 'occult' if they cannot. Wet macular degeneration usually occurs in people who already have dry macular degeneration. Of these two conditions, wet macular degeneration progresses more quickly and vision loss is more severe.

Laser therapy is used to coagulate new vessels in wet macular degeneration. However, the procedure itself may permanently impair vision, especially if the vessels are very close to the fovea. Recurrence is common. Laser therapy appears to work only in people with classic neovascular macular degeneration.

Other new treatments for macular degeneration include surgery to remove new vessels, radiotherapy, photodynamic therapy, and new drugs that suppress new vessel formation (antiangiogenic drugs).

Macular translocation involves moving the macula so that the fovea lies over a healthier part of the choroid. This may involve detaching and rotating the retina (macular translocation with 360o retinotomy), or making an incision in the retina, folding the outer layers of the eye, making the sclera shorter and moving the choroid slightly in relation to the macula (limited macular translocation).

No controlled studies were identified. One study on limited macular translocation found this procedure to lead to improved visual acuity in 34 out of 86 eyes (40%) with AMD. This study, however, also found deterioration in visual acuity in 27 out of 86 eyes (31%). In this study the estimated incidence of recurrence was 35% in 86 eyes. For more details, refer to the Overview (see Appendix).

One study on 360o retinotomy macular translocation found that visual acuity improved in 28% (24/87 patients) and deteriorated in 33% (29/87 patients). Another study found that visual acuity improved in 66% (33/50 patients) and deteriorated in 6% (3/50 patients). For more details, refer to the sources of evidence (see Appendix).

The Specialist Advisors commented that anatomical success is not always associated with visual improvement. There are cases where the fovea has been moved, but the vision deteriorated rather than improved. However, improvement can sometimes be dramatic.

In the studies identified for limited macular translocation, the most common intraoperative complications noted were: macular holes (1-8%); retinal tear (5-6%); haemorrhage (vitreous: 2%, subretinal: 1-5% or choroidal: 1-4%); and scleral perforation (2%). The most common postoperative complications were: retinal detachment (9-19%); retinal tear (4-8%); macular fold (3-5%); vitreous haemorrhage (2-3%); and new vessels at retinotomy site (1-2%). For more details, refer to the sources of evidence (see Appendix).

In the studies identified for 360o retinotomy macular translocation, the most common complications noted were: corneal erosion (100%); macular oedema (29%); proliferative vitreoretinopathy (7-8%); retinal detachment (19%); peripheral epiretinal membranes (8%); and macular pucker (6%). For more details, refer to the sources of evidence (see Appendix).

The Specialist Advisors noted retinal detachment, retinal bleeding, proliferative vitreoretinopathy (PVR), double vision and constriction of the visual fields as potential adverse events. One Advisor considered that the long-term results and complications would be similar to those associated with creating and repairing a retinal detachment.

The Advisory Committee were particularly concerned that the vision of some patients deteriorates after the procedure. They also commented that the evidence base is poor.

NICE issued guidance on the use of photodynamic therapy for age-related macular degeneration in September 2003 (www.nice.org.uk/pdf/68_PDTGuidance.pdf)

The following document, which summarises the evidence, was considered by the Interventional Procedures Advisory Committee when making it's provisional recommendations.

• Interventional Procedure Overview of Macular translocation for age-related macular degeneration, December 2002

Available from: www.nice.org.uk/ip080overview