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Posterior Capsular Opacification and Glistenings in Hydrophobic and Hydrophilic Intraocular Lenses

Primary Purpose

Cataract, Intraocular Lens Opacification

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
RayOne® Hydrophobic lens 800C
RayOne® Hydrophilic lens 600C
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. Unilateral or bilateral 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 less than 1 diopter in both eyes.

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

    Active Comparator

    Active Comparator

    Arm Label

    RayOne® Hydrophilic lens 600C

    RayOne® Hydrophobic lens 800C

    Arm Description

    Patients will be randomly selected to receive the monofocal, acrylic, RayOne® Hydrophilic lens 600C

    Patients will be randomly selected to receive the monofocal, acrylic, RayOne® Hydrophobic lens 800C

    Outcomes

    Primary Outcome Measures

    Posterior Capsular Opacification of Intraocular Lens
    Degree of the Posterior Capsular Opacification of Intraocular Lens will be assessed using digital imaging techniques
    Intraocular lens glistenings
    Degree of the intraocular lens glistenings will be quantified using digital analysis
    Intraocular lens tilt and decentration

    Secondary Outcome Measures

    Visual Acuities
    Unaided and Best corrected Logmar Visual acuity for distance, and for near vision will be assessed
    Forward light scatter and Contrast Sensitivity Measurement
    Forward light scatter and Contrast Sensitivity Measurement will be quantified using computerised visual testing
    Patient Satisfaction
    Validated questionnaires will be used to assess patient satisfaction
    Intraoperative and post operative complications

    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
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04122664
    Brief Title
    Posterior Capsular Opacification and Glistenings in Hydrophobic and Hydrophilic Intraocular Lenses
    Official Title
    Prospective Randomized Controlled Study Measuring Posterior Capsular Opacification, Lens Glistenings, Tilt and Decentration, and Visual Outcomes Following Insertion of the RayOne Hydrophobic Lens 800C and the RayOne Hydrophilic Lens 600C.
    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
    May 2022 (Anticipated)
    Study Completion Date
    May 2022 (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
    A prospective randomized controlled clinical study to measure posterior capsular opacification, objective measurement of glistenings and intraocular lens tilt and decentration as well as visual outcomes following insertion of a monofocal, aspheric, hydrophobic acrylic intraocular lens: the RayOne® Hydrophobic lens 800C and a monofocal aspheric, hydrophilic acrylic intraocular lens: the RayOne® Hydrophilic lens 600C

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cataract, Intraocular Lens Opacification

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Masking Description
    Patients randomised into one of two groups
    Allocation
    Randomized
    Enrollment
    176 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    RayOne® Hydrophilic lens 600C
    Arm Type
    Active Comparator
    Arm Description
    Patients will be randomly selected to receive the monofocal, acrylic, RayOne® Hydrophilic lens 600C
    Arm Title
    RayOne® Hydrophobic lens 800C
    Arm Type
    Active Comparator
    Arm Description
    Patients will be randomly selected to receive the monofocal, acrylic, RayOne® Hydrophobic lens 800C
    Intervention Type
    Device
    Intervention Name(s)
    RayOne® Hydrophobic lens 800C
    Intervention Description
    Patients will receive a monofocal, aspheric, hydrophobic acrylic intraocular lens: the RayOne® Hydrophobic lens 800C
    Intervention Type
    Device
    Intervention Name(s)
    RayOne® Hydrophilic lens 600C
    Intervention Description
    Patients will receive a monofocal aspheric, hydrophilic acrylic intraocular lens: the RayOne® Hydrophilic lens 600C.
    Primary Outcome Measure Information:
    Title
    Posterior Capsular Opacification of Intraocular Lens
    Description
    Degree of the Posterior Capsular Opacification of Intraocular Lens will be assessed using digital imaging techniques
    Time Frame
    24 months
    Title
    Intraocular lens glistenings
    Description
    Degree of the intraocular lens glistenings will be quantified using digital analysis
    Time Frame
    24 months
    Title
    Intraocular lens tilt and decentration
    Time Frame
    24 months
    Secondary Outcome Measure Information:
    Title
    Visual Acuities
    Description
    Unaided and Best corrected Logmar Visual acuity for distance, and for near vision will be assessed
    Time Frame
    24 months
    Title
    Forward light scatter and Contrast Sensitivity Measurement
    Description
    Forward light scatter and Contrast Sensitivity Measurement will be quantified using computerised visual testing
    Time Frame
    24 months
    Title
    Patient Satisfaction
    Description
    Validated questionnaires will be used to assess patient satisfaction
    Time Frame
    24 months
    Title
    Intraoperative and post operative complications
    Time Frame
    0 days-24 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: Unilateral or bilateral 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 less than 1 diopter in both eyes. 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

    Posterior Capsular Opacification and Glistenings in Hydrophobic and Hydrophilic Intraocular Lenses

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