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Femtosecond Laser Assisted Cataract Surgery in The NHS

G

Guy's and St Thomas' NHS Foundation Trust

Status

Completed

Conditions

Cataract
Surgery

Treatments

Procedure: Conventional cataract surgery (phacoemulsification)
Procedure: Femtosecond laser assisted cataract surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT02825693
ILH297-P002

Details and patient eligibility

About

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).

Enrollment

400 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

400 participants in 2 patient groups

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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