Limited macular translocation for wet age-related macular degeneration - Consultation Document

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE

Interventional procedure consultation document

Limited macular translocation for wet age-related macular degeneration

Age-related macular degeneration (AMD) is an eye disorder affecting the macula, which is the area at the centre of the retina (the back of the eye) responsible for central vision (seeing things straight in front of you). Wet AMD happens because fluid leaks out of abnormally formed arteries and veins into the area under the macula (the choroid layer), causing scarring.

Limited macular translocation aims to improve vision. It involves cutting the macula and moving it to a nearby healthier area of the choroid layer.

A small incision is made in the retina to get to the outer layers of the eye. A ‘tuck’ is then made in these layers with a stitch, so that the macula lies over a different part of the choroid layer. This ‘tuck’ method is called limited macular translocation.

The National Institute for Health and Clinical Excellence (NICE) is examining limited macular translocation for wet age-related macular degenerationand will publish guidance on its safety and efficacy to the NHS in England, Wales, Scotland and Northern Ireland. NICE’s Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisers, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about limited macular translocation for wet age-related macular degeneration.

This document summarises the procedure and sets out the provisional recommendations made by the Advisory Committee. It has been prepared for public consultation. The Advisory Committee particularly welcomes:

  • comments on the provisional recommendations
  • the identification of factual inaccuracies
  • additional relevant evidence, with bibliographic references where possible.

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

The process that NICE 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  • The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.

For further details, see the Interventional Procedures Programme manual, which is available from the NICE website (www.nice.org.uk/ipprogrammemanual).

NICE is committed to promoting through its guidance race and disability equality and equality between men and women, and to eliminating all forms of discrimination. One of the ways we do this is by trying to involve as wide a range of people and interest groups as possible in the development of our guidance on interventional procedures. In particular, we aim to encourage people and organisations from groups in the population who might not normally comment on our guidance to do so. We also ask consultees to highlight any ways in which draft guidance fails to promote equality or tackle discrimination and give suggestions for how it might be improved. NICE reserves the right to summarise and edit comments received during consultations, or not to publish them at all, where in the reasonable opinion of NICE, the comments are voluminous, publication would be unlawful or publication would otherwise be inappropriate.

Closing date for comments: 27 January 2010

Target date for publication of guidance: April 2010

 

1       Provisional recommendations

1.1  Current evidence on limited macular translocation for wet age-related macular degeneration (AMD) shows that this procedure is efficacious only in a proportion of patients and that there is a potential for serious adverse events. Therefore the procedure should only be used with special arrangements for clinical governance, consent and audit or research. 

1.2  Clinicians wishing to undertake limited macular translocation for wet AMD should take the following actions.

·     Inform the clinical governance leads in their Trusts.

·     Ensure that patients and their carers understand the uncertainty about the procedure’s safety and efficacy and provide them with clear information about both this procedure and alternative treatments. In addition, the use of NICE’s information for patients (‘Understanding NICE guidance’) is recommended (available from www.nice.org.uk/IPG80apublicinfo). [[details to be completed at publication]]

·     Audit and review clinical outcomes of all patients having limited macular translocation for wet AMD (see section 3.1).

2       The procedure

2.1    Indications and current treatments

2.1.1  Age-related macular degeneration is the most common cause of blindness in developed countries. A small proportion of patients with AMD have wet AMD (also known as neovascular or exudative AMD). Wet AMD is characterised by the abnormal growth of blood vessels in the choroid layer underneath the macular part of the retina. These vessels can threaten vision if they leak and cause scarring.

2.1.2  Depending on disease stage, current treatments for wet AMD may include laser photocoagulation, photodynamic therapy, intravitreal injections of antivascular endothelial growth factor agents and implantation of miniature lens systems. Patients with advanced disease may benefit from optical aids such as magnifying glasses.

2.2    Outline of the procedure

2.2.1  The aim of limited macular translocation for wet AMD is to move the macula so that it lies over a healthier part of the choroid layer that is unaffected by neovascularisation. The technique was developed as a less invasive alternative to macular translocation with 360° retinotomy.

2.2.2  Limited macular translocation involves making a short incision in the retina to allow fluid to be injected under the retina, so detaching it from the underlying choroid. The outer layers of the eye are then folded and secured with a stitch (scleral imbrication) so that the underlying choroid layer is moved slightly in relation to the macula.

Sections 2.3 and 2.4 describe efficacy and safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview, available at www.nice.org.uk/IP80aoverview.

 

2.3    Efficacy

2.3.1  A case series of 151 patients reported that 41% (35/86) of patients had best-corrected visual acuity (BCVA) of 20/100 or better, and 40% (34/86) of patients had improved BCVA by 2 or more lines at 12-month follow-up (mean BCVA at baseline was 20/160). A non-randomised controlled study of 65 patients reported that mean improvement in BCVA was significantly greater following limited macular translocation (+0.5 lines) (n = 21) than following photodynamic therapy (–3.4 lines) (n = 20) at 12-month follow-up (p = 0.007). 

2.3.2  In the case series of 151 patients, 60% (52/86) of patients achieved median foveal displacement of 1200 micrometres at 12-month follow-up (described as ‘effective’ translocation). A case series of 25 patients reported median foveal displacement of 1142 micrometres (described as ‘successful’ translocation) in 68% (17/25) of patients (follow-up not stated).

2.3.3  In the non-randomised controlled study of 65 patients, recurrence of neovascularisation was reported in 13 eyes treated by limited macular translocation at mean follow-up of 4.8 months.

2.3.4  The Specialist Advisers listed key efficacy outcomes as visual acuity, reading speed and quality of life.

2.4    Safety

2.4.1  The non-randomised controlled study of 65 patients reported that 38% of eyes treated by limited macular translocation (n = 36) experienced 1 or more postoperative complications (absolute figures not stated). A mean BCVA loss of 4.8 lines was reported for these eyes.

2.4.2  In the non-randomised controlled study of 65 patients, retinal detachment due to a peripheral tear, and requiring additional surgery, was reported in 5 eyes among the 29 patients treated by limited macular translocation at a mean follow-up of 3.2 months. Postoperative retinal detachment occurred in 16% (25/153) of eyes in a case series of 151 patients at follow-up between 1 and 13 weeks, with 84% (21/25) of these requiring additional surgery. The frequency of retinal detachment decreased significantly in patients treated later in the series (p = 0.006). A retinal break (not otherwise described) was reported in 8% (13/153) of eyes in the case series of 151 patients.

2.4.3  Intermittent or continuous diplopia after limited macular translocation was reported in 6% (14/250) of patients in a case series of 250 patients (management and follow-up not stated). Diplopia was reported in 1 patient in a case report of 2 patients (symptoms resolved without additional surgery by 5-month follow-up).

2.4.4  The Specialist Advisers listed suprachoroidal haemorrhage as an adverse event reported in the literature. They listed anecdotal or observed adverse events as diplopia, cataract and persistent retinal fold in the macular area. They considered theoretical events to include endophthalmitis and recurrence of the condition.

2.5.1  Other comments

2.5.2  The Committee noted that intravitreal injections of antivascular endothelial growth factor agents are more commonly used for the treatment of AMD than surgical techniques. For more information see ‘Ranibizumab and pegaptanib for the treatment of age-related macular degeneration’ (NICE technology appraisal guidance 155) available from www.nice.org.uk/TA155.

3     Further information

3.1  This guidance requires that clinicians undertaking the procedure make special arrangements for audit. NICE has identified relevant audit criteria and is developing an audit tool (which is for use at local discretion), which will be available when the guidance is published.

3.2  For related NICE guidance see www.nice.org.uk.

Bruce Campbell
Chairman, Interventional Procedures Advisory Committee
December 2009

Personal data will not be posted on the NICE website. In accordance with the Data Protection Act names will be anonymised, other than in circumstances where explicit permission has been given.

 It is the responsibility of consultees to accurately cite academic work in order that they can be validated.

This page was last updated: 30 March 2010