Femtosecond Laser Assisted Cataract Surgery in The NHS

Study Overview
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Brief Summary
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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).

Official Title
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The Development of Surgical Pathways Using Femto-second Laser Technology to Increase the Efficiency and Safety of Cataract Surgery Within a Public Health Sector Setting - A Randomised Controlled Trial

Conditions
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Cataract, Surgery

Intervention / Treatment
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* Procedure: Conventional cataract surgery (phacoemulsification)
* Procedure: Femtosecond laser assisted cataract surgery


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Femtosecond laser cataract surgery<br>Cataract surgery with femtosecond laser treatment for corneal incisions, astigmatic keratotomies, capsulotomy and nuclear fragmentation | Procedure: Femtosecond laser assisted cataract surgery<br> <br> |
| Active Comparator: Conventional phacoemulsification surgery<br>Conventional phacoemulsification surgery | Procedure: Conventional cataract surgery (phacoemulsification)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost-analysis: Healthcare resource use attributable to managing patients in this study will be collected. | 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. | up to 2 months |