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Femtosecond Laser Assisted Cataract Surgery in The NHS

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ClinicalTrials.gov Identifier: NCT02825693
Recruitment Status : Completed
First Posted : July 7, 2016
Last Update Posted : July 23, 2020
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Cataract Surgery Procedure: Conventional cataract surgery (phacoemulsification) Procedure: Femtosecond laser assisted cataract surgery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : August 2016
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

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
Conventional phacoemulsification surgery
Procedure: Conventional cataract surgery (phacoemulsification)



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
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Responsible Party: Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02825693    
Other Study ID Numbers: ILH297-P002
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: July 23, 2020
Last Verified: February 2020
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases