Femtosecond Laser Assisted Cataract Surgery in The NHS

July 22, 2020 updated by: Guy's and St Thomas' NHS Foundation Trust

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

June 30, 2018

Study Registration Dates

First Submitted

June 20, 2016

First Submitted That Met QC Criteria

July 4, 2016

First Posted (Estimate)

July 7, 2016

Study Record Updates

Last Update Posted (Actual)

July 23, 2020

Last Update Submitted That Met QC Criteria

July 22, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ILH297-P002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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