Femtosecond Laser Assisted Cataract Surgery in The NHS

NCT02825693 | Completed

• 1 other identifier: ILH297-P002
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Cataract; Surgery

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Femtosecond laser cataract surgery

ACTIVE COMPARATOR

Cataract surgery with femtosecond laser treatment for corneal incisions, astigmatic keratotomies, capsulotomy and nuclear fragmentation

Procedure: Femtosecond laser assisted cataract surgery

Conventional phacoemulsification surgery

ACTIVE COMPARATOR

Conventional phacoemulsification surgery

Procedure: Conventional cataract surgery (phacoemulsification)

Interventions

Conventional cataract surgery (phacoemulsification) PROCEDURE

Conventional phacoemulsification surgery

Femtosecond laser assisted cataract surgery PROCEDURE

Femtosecond laser cataract surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Children below the age of 18
• Already enrolled in another study
• Significant corneal opacities
• Small pupils following pharmacological dilatation
• Patients unable to lie sufficiently flat so as to be positioned underneath the laser machine.

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

MeSH Terms

Conditions

Cataract

Interventions

Phacoemulsification

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Cataract Extraction; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Ultrasonic Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2016
• First Posted: July 7, 2016
• Study Start: August 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 30, 2018
• Last Updated: July 23, 2020

Record last verified: 2020-02