search
Back to results

Toric Intraocular Lenses for Cataract Patients in the NHS

Primary Purpose

Cataract, Astigmatism, Cornea

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
'Off the shelf' toric lens
Tailored Toric lens
Sponsored by
Guy's and St Thomas' NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Bilateral or unilateral cataracts requiring surgical intervention
  2. Age over 18 years
  3. Able to understand informed consent and the objectives of the trial
  4. Not pregnant, not breast feeding
  5. No previous eye surgery
  6. Corneal astigmatism greater than 1.5 diopters in one eye.

Exclusion Criteria:

  1. age-related macula degeneration
  2. glaucoma
  3. previous retinal vascular disorders
  4. previous retinal detachment or tear
  5. any neuro-ophthalmological condition
  6. any inherited retinal disorder or pathology
  7. previous strabismus surgery or record of amblyopia
  8. previous TIA, CVA or other vaso-occlusive disease
  9. already enrolled in another study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Experimental Arm

    Control Arm

    Arm Description

    Patients will be receiving a toric intraocular lens with either a 2.00 or 4.00 diopter (D) correction, depending on the degree of pre-operative astigmatism, and the astigmatic refractive error will be refined with the use of adjunctive limbal relaxing incisions LRIs and/or off axis rotation of the toric IOL (based on a standardized protocol) so the full amount of corneal astigmatism can be targeted for correction for each patient.

    The patient will receive a toric intraocular lens individually tailored to and ordered for each patients' precise degree of corneal astigmatism.

    Outcomes

    Primary Outcome Measures

    Visual Acuities
    Corrected and uncorrected Logmar Visual Acuities
    Refractive Error

    Secondary Outcome Measures

    Intraoperative and post operative complications
    Patient Satisfaction
    Patient satisfaction scores using validated questionnaires

    Full Information

    First Posted
    October 8, 2019
    Last Updated
    October 9, 2019
    Sponsor
    Guy's and St Thomas' NHS Foundation Trust
    Collaborators
    City, University of London, King's College London
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04122651
    Brief Title
    Toric Intraocular Lenses for Cataract Patients in the NHS
    Official Title
    Randomised, Controlled Study Comparing Use of "Off the Shelf" Toric Lenses, With Set Cylindrical Corrections (2.00D or 4.00D) and Combined Limbal Relaxing Incisions and/or Off-axis Lens Rotation, With Fully Targeted Toric Lens Correction.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 14, 2019 (Anticipated)
    Primary Completion Date
    August 2020 (Anticipated)
    Study Completion Date
    August 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Guy's and St Thomas' NHS Foundation Trust
    Collaborators
    City, University of London, King's College London

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To assess visual performance, refractive outcome, and patient satisfaction with the use of "off the shelf" toric lenses, with a set cylindrical correction of 2.00 or 4.00 diopters, and combined limbal relaxing incisions and/or off-axis intraocular lens rotation, compared to fully targeted toric intraocular lens correction.
    Detailed Description
    The aim of this study is to evaluate a simplified, more cost-effective procedure for the use of toric intraocular lenses, with a focus on suitability for NHS cataract surgery. This study will involve the use of standard, "off-the-shelf" toric lenses rather than having them specifically tailored and ordered for each individual patient. Eligible participants (>1.25 D of corneal astigmatism) will be randomised, receiving a toric IOL with either a 2.00 or 4.00 diopter (D) correction, depending on the degree of pre-operative astigmatism, or a toric IOL individually tailored to and ordered for each patients' precise degree of corneal astigmatism. With the "off the shelf" toric IOL group the correction of the astigmatic refractive error will be refined with the use of adjunctive limbal relaxing incisions LRIs and/or off axis rotation of the toric IOL (based on a standardized protocol) so the full amount of corneal astigmatism can be targeted for correction for each patient. The clinical outcome will then be measured and compared between the 2 groups. Independent safety monitoring will be performed.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cataract, Astigmatism, Cornea

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Rayone Toric intraocular lens (for cataract surgery)
    Masking
    Participant
    Masking Description
    Patients will be randomised into one of two groups.
    Allocation
    Randomized
    Enrollment
    168 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental Arm
    Arm Type
    Experimental
    Arm Description
    Patients will be receiving a toric intraocular lens with either a 2.00 or 4.00 diopter (D) correction, depending on the degree of pre-operative astigmatism, and the astigmatic refractive error will be refined with the use of adjunctive limbal relaxing incisions LRIs and/or off axis rotation of the toric IOL (based on a standardized protocol) so the full amount of corneal astigmatism can be targeted for correction for each patient.
    Arm Title
    Control Arm
    Arm Type
    Active Comparator
    Arm Description
    The patient will receive a toric intraocular lens individually tailored to and ordered for each patients' precise degree of corneal astigmatism.
    Intervention Type
    Procedure
    Intervention Name(s)
    'Off the shelf' toric lens
    Intervention Description
    'Off the shelf' toric lens (either 2.00D or 4.00D) and combined limbal relaxing incisions and/or off-axis inttaocular lens rotation
    Intervention Type
    Procedure
    Intervention Name(s)
    Tailored Toric lens
    Intervention Description
    Fully targeted toric intraocular lens correction for corneal astigmatism
    Primary Outcome Measure Information:
    Title
    Visual Acuities
    Description
    Corrected and uncorrected Logmar Visual Acuities
    Time Frame
    6 months
    Title
    Refractive Error
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Intraoperative and post operative complications
    Time Frame
    0 day-6 months
    Title
    Patient Satisfaction
    Description
    Patient satisfaction scores using validated questionnaires
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Bilateral or unilateral cataracts requiring surgical intervention Age over 18 years Able to understand informed consent and the objectives of the trial Not pregnant, not breast feeding No previous eye surgery Corneal astigmatism greater than 1.5 diopters in one eye. Exclusion Criteria: age-related macula degeneration glaucoma previous retinal vascular disorders previous retinal detachment or tear any neuro-ophthalmological condition any inherited retinal disorder or pathology previous strabismus surgery or record of amblyopia previous TIA, CVA or other vaso-occlusive disease already enrolled in another study
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Khayam Naderi, MBBS BSc MA
    Phone
    020 7188 7188
    Ext
    84331
    Email
    khayam.naderi@gstt.nhs.uk

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Toric Intraocular Lenses for Cataract Patients in the NHS

    We'll reach out to this number within 24 hrs