Scleral expansion surgery for presbyopia

# Guidance
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 concerns about the potential risks of the procedure.
It is recommended that this procedure should not be used. The Institute's information for the public complements this guidance in explaining the concerns about the procedure.# The procedure

# Indications
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 ability to focus on close objects.
Standard treatment for presbyopia is the use of corrective spectacles. As the condition worsens, prescriptions need to be changed accordingly.

# Outline of the procedure
Scleral expansion surgery involves making small incisions in the eye and inserting bands to stretch the part of the sclera that lies beneath the ciliary muscles that control accommodation. This procedure is claimed to improve accommodation.

# Efficacy
All studies identified were of poor quality. The evidence was limited to one non-randomised controlled study of 29 patients, two very small case series (of six and three patients, respectively) 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 3/8 eyes (38%), but it was no better than before surgery at day 360. In the same study, implanted bands were removed from three eyes upon patient request because of lack of benefit. In another case series of three patients, scleral expansion surgery failed to restore accommodation in any patients. For more details, refer to the Sources of evidence section.
The Specialist Advisors considered the evidence to suggest that the procedure is not efficacious. One Advisor noted that the procedure was controversial because it was based on a novel theory of the mechanism of accommodation of the human eye that was in direct opposition to other generally accepted theories.

# Safety
The complications reported in the identified studies were: two case reports of band removal because of band migration or chronic pain and swelling; two cases of perforated conjunctiva in a study of 8 patients; and one report of transient elevation of intraocular pressure in a study of 29 patients. For more details, refer to the Sources of evidence section.
The Specialist Advisors listed the main potential adverse events as intraocular haemorrhage, retinal detachment, endophthalmitis, glaucoma, conjunctival scarring and scleral thinning.
Andrew DillonChief ExecutiveJuly 2004# Further information

# Sources of evidence
The evidence considered by the Interventional Procedures Advisory Committee is described in the following document.
'Interventional procedure overview of sclera expansion surgery for presbyopia', April 2003.

# Information for the public
NICE has produced information on this procedure for patients and carers ('Understanding NICE guidance'). It explains the nature of the procedure and the guidance issued by NICE, and has been written with patient consent in mind.# About this guidance
NICE interventional procedure guidance makes recommendations on the safety and efficacy of the procedure. It does not cover whether or not the NHS should fund a procedure. Funding decisions are taken by local NHS bodies after considering the clinical effectiveness of the procedure and whether it represents value for money for the NHS. It is for healthcare professionals and people using the NHS in England, Wales, Scotland and Northern Ireland, and is endorsed by Healthcare Improvement Scotland for implementation by NHSScotland.
This guidance was developed using the NICE interventional procedure guidance process.
We have produced a summary of this guidance for patients and carers. Information about the evidence it is based on is also available.
Changes since publication
January 2012: minor maintenance.
Your responsibility
This guidance represents the views of NICE and was arrived at after careful consideration of the available evidence. Healthcare professionals are expected to take it fully into account when exercising their clinical judgement. This guidance does not, however, override the individual responsibility of healthcare professionals to make appropriate decisions in the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
Implementation of this guidance is the responsibility of local commissioners and/or providers. Commissioners and providers are reminded that it is their responsibility to implement the guidance, in their local context, in light of their duties to avoid unlawful discrimination and to have regard to promoting equality of opportunity. Nothing in this guidance should be interpreted in a way which would be inconsistent with compliance with those duties.
Copyright
 National Institute for Health and Clinical Excellence 2004. All rights reserved. NICE copyright material can be downloaded for private research and study, and may be reproduced for educational and not-for-profit purposes. No reproduction by or for commercial organisations, or for commercial purposes, is allowed without the written permission of NICE.
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