The National Institute for Clinical Excellence is examining scleral expansion surgery for presbyopia and will publish guidance on its safety and efficacy to the NHS in England, Wales and Scotland. 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 scleral expansion surgery for presbyopia.

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 preliminary recommendation
• the identification of factual inaccuracies
• additional relevant evidence.

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• The Advisory Committee will then prepare draft guidance, which will be the basis for the Institute's guidance on the use of the procedure in the NHS in England, Wales and Scotland.

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: 27 April 2004

Target date for publication of guidance: July 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 on the safety and efficacy of scleral expansion surgery for presbyopia is very limited. There is no evidence of efficacy in the majority of patients. There are also potential safety concerns about the procedure.

The Advisory Committee recommends that this procedure should not be used.

Presbyopia is an age-related and progressive loss of focusing power of the lens in the eye. It leads to a gradual decline in the ablility to focus on close objects.

Standard treatment for presbyopia is the use of corrective lenses (spectacles or contact lenses). As the condition worsens, prescriptions need to be changed accordingly.

Scleral expansion surgery involves making small incisions in the eye and inserting bands to stretch the part of the sclera (the tough fibrous layer of the eyeball) that lies beneath the muscles controlling accommodation (ciliary muscles). This procedure is claimed to improve accommodation.

All studies identified were of poor quality. The evidence was limited to one non-randomised controlled study, two very small case series (n=6 and n=3) and two case reports. In the controlled study, in which the dominant eye was operated on and the other eye served as a control, improvement in median reading acuity score at 20 cm was reported as - 0.41 for operated eyes and - 0.35 for control eyes (p < 0.03), indicating that the improvement in operated eyes was greater. No significant difference in reading acuity was found at 30 cm or 40 cm. One case series reported that near visual acuity improved temporarily in 38% (3/8) of eyes, but was no better than before surgery at day 360. In this study implanted bands were removed from 38% (3/8) of eyes upon patient request because of lack of benefit. Another case series found that scleral expansion surgery failed to restore accommodation in 100% (3/3) of patients. For more details, refer to the sources of evidence (see Appendix).

The Specialist Advisors considered the evidence to suggest that the procedure is not efficacious. One Advisor noted that the procedure was controversial as it was based on a novel theory of the mechanism of accommodation of the human eye, which was in direct opposition to the generally accepted theories of Young and Helmholtz.

The complications reported in the identified studies were band migration to the surface, requiring removal of band 100% (1/1); chronic pain and swelling requiring removal of band 100% (1/1); perforated conjunctiva 25% (2/8); and transient elevation of intraocular pressure 3% (1/29). For more details, refer to the sources of evidence (see Appendix).

The Specialist Advisors listed the main potential adverse events as intraocular haemorrhage, retinal detachment, endophthalmitis, glaucoma, conjunctival scarring, and scleral thinning.

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

• Interventional procedure overview of scleral expansion surgery for presbyopia, April 2003

Available from: www.nice.org.uk/ip048overview