Femtosecond Laser Assisted Cataract Surgery in The NHS

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02825693
• Other study ID #: ILH297-P002
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: June 30, 2018

Study information

• Verified date: February 2020
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: June 30, 2018
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Surgery

Intervention

Procedure:
• Conventional cataract surgery (phacoemulsification)

• Femtosecond laser assisted cataract surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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