2 The procedure

2.1 Indications

2.1.1 Age-related macular degeneration (AMD) is characterised by damage to the central part of the retina (the macula) resulting in progressive loss of central vision. Peripheral vision is not affected so individuals retain some useful vision. The prevalence of macular degeneration increases with age.

2.1.2 Ninety percent of people with 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. They 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.

2.1.3 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 (subfoveal vessels). Recurrence is common. Laser therapy appears to work only in people with classic neovascular macular degeneration.

2.1.4 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).

2.2 Outline of the procedure

2.2.1 Transpupillary thermotherapy uses laser energy to coagulate vessels in wet macular degeneration and is intended to alter the progression of the disease and to preserve vision. This procedure uses a lower-power, more diffuse beam than standard laser treatment. It may be used to treat patients with occult new vessels.

2.3 Efficacy

2.3.1 All studies identified were uncontrolled and relatively small with a mean follow-up of no greater than 10 months. The majority of patients in the studies had occult or predominantly occult subfoveal new vessels. Visual acuity improved in 0% (0/12) to 32% (9/28) of eyes and deteriorated in 9% (5/57) to 43% (12/28) of eyes in the studies identified. For more details, refer to the 'Sources of evidence' section.

2.3.2 A Specialist Advisor considered that optimal treatment protocols have yet to be established.

2.4 Safety

2.4.1 The main safety findings reported in the studies reviewed were: large submacular haemorrhage in the first 2 months, 6% (3/49 patients); postoperative haemorrhage, 5% (3/66 eyes); and macular infarction, 1% (1/77 patients). For more details, refer to the 'Sources of evidence' section.

2.4.2 The Specialist Advisors considered there to be a risk of unwanted thermal damage to the retina and pigment epithelium.