Femtosecond Laser Assisted Cataract Surgery in The NHS

Not Applicable

Completed

• Conditions: Surgery; Cataract
• Interventions: Procedure: Femtosecond laser assisted cataract surgery; Procedure: Conventional cataract surgery (phacoemulsification)

• Registration Number: NCT02825693
• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust

Brief Summary

This study aims to examine the health economic impact of adopting femtosecond laser technology to assist high volume cataract surgery (FLACS) within a state-funded healthcare system, the National Health Service (NHS).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-20
• Study First Submitted QC: 2016-07-04
• Study First Posted: 2016-07-07
• Study Start: 2016-08
• Primary Completion: 2017-06
• Study Completion: 2018-06-30
• Status Verified: 2020-02
• Last Update Submitted: 2020-07-22
• Last Update Posted: 2020-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Patients must have reduced visual acuity or visual symptoms attributed to the presence of cataract in one or both eyes by the examining ophthalmologist or else must require cataract surgery on clinical grounds other than visual symptoms.
• Patients must be willing to attend for follow-up at 1 month after cataract surgery.
• Patients must be sufficiently fluent in English for informed consent and self-completion of the patient reported outcome questionnaires.

Exclusion Criteria

• Children below the age of 18
• Already enrolled in another study

The principle exclusion criteria relate to clinical contraindications for FLACS, such as:

• Significant corneal opacities
• Small pupils following pharmacological dilatation
• Patients unable to lie sufficiently flat so as to be positioned underneath the laser machine.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Femtosecond laser cataract surgery	Femtosecond laser assisted cataract surgery	Cataract surgery with femtosecond laser treatment for corneal incisions, astigmatic keratotomies, capsulotomy and nuclear fragmentation
Conventional phacoemulsification surgery	Conventional cataract surgery (phacoemulsification)	Conventional phacoemulsification surgery

Primary Outcome Measures

Name	Time	Method
Cost-analysis: Healthcare resource use attributable to managing patients in this study will be collected.	up to 2 months	These include (but not necessarily be limited to) the cost of surgery for both arms of the trial (including resource use and staffing levels required for the surgical protocols), resource use attributable to managing complications arising from surgery, all relevant diagnostic investigations, further surgery where necessary, hospital length of stay and ward type, outpatient attendances, procedures performed on an outpatient basis, Accident \& Emergency attendances and prescribed drug medications. The quantity of resource use for each cost component will be measured from medical records. Site-specific unit costs will be taken in preference of standard published sources or national tariffs where possible.