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Completed

NCT Number: NCT03364972

A Study Comparing Two Monofocal, Aspheric, Hydrophobic Acrylic Intraocular Lenses: the Alcon CLAREON® and the Abbott Medical Optics PCB00

This is a bilateral randomised controlled study to compare visual performance, refractive outcome, forward light scatter, patient satisfaction and objective measurement of glistenings following insertion of two monofocal, aspheric, hydrophobic acrylic intraocular lenses (IOLs). A new product is compared with an established one.

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Key information

Conditions

Cataract Extraction Behavior Cataract Cataract Surgery Eye Diseases Glistenings Health Behavior Hydrophobic Acrylic Intraocular Lens Implant Lens Diseases Light Scatter Patient Related Outcome Measures Patient Satisfaction Phacoemulsification Treatment Adherence and Compliance

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Thomas' Hospital NHS Trust

London, SE1 7EH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • bilateral cataracts
  • good visual potential
  • ability to understand informed consent and 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 transient ischaemic attacks, cerebrovascular events or other vaso-occlusive disease
  • already enrolled in another study
  • Exclusion criteria relate to clinical contraindications for Femtosecond Laser Assisted Cataract Surgery, 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

Treatment and study plan

Cataract surgery

Device

Conventional small-incision phacoemulsification cataract surgery with insertion of intraocular lens implant

Primary outcomes

  1. Visual acuity

    Time frame: 13 months

    As measured by conventional LogMAR visual acuity charts

Secondary outcomes

  1. Incidence of intraocular lens glistenings

    Time frame: 13 months

    Incidence of presence of intraocular lens glistenings in each study arm

  2. Severity of intraocular lens glistenings

    Time frame: 13 months

    Number of vacuoles per square millimetre

  3. Refraction (i.e. glasses prescription)

    Time frame: 13 months

    In conventional sphere/cylinder dioptre scales: total range -40 to +40, in 0.25 steps. Higher values represent worse outcome. Values closer to 0 (zero) represent better outcome

Other outcomes

  1. Forward light scatter

    Time frame: 13 months

    Intraocular (forward) light scatter is measured with a specifically devised computerised vision test. It is represented by straylight parameter, Log(s), on a logarithmic scale from 0 to 1.5. The lower the value (i.e. closer to 0), the better the outcome.

  2. Contrast sensitivity

    Time frame: 13 months

    Visual acuity (LogMAR scale: total range -0.2 to 1.0 in 0.02 steps) measured at different contrasts with a computerized contrast sensitivity chart. Negative values, or values closer to 0, represent better outcome.

  3. Patient satisfaction

    Time frame: 13 months

    Validated patient satisfaction questionnaire. We use specially designed and validated conversion tables to convert raw scores from questionnaires to Rasch calibrated measures.

  4. Self-reported health

    Time frame: 13 months

    Validated self-reported health questionnaire. We use a vertical Visual Analogue Scale (VAS) to record patients' self-reported health on a scale from 0-100 (values closer or equal to 100 represent better outcome).

Sponsors and collaborators

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust

Other

Collaborators

  • City, University of London
  • King's College London

Registry information

Official study title

A Randomised, Controlled Study to Compare Visual Performance, Refractive Outcome, Forward Light Scatter, Patient Satisfaction and Objective Measurement of Glistenings Following Insertion of Two Monofocal, Aspheric, Hydrophobic Acrylic Intraocular Lenses: the Alcon CLAREON® and the Abbott Medical Optics PCB00 Lenses

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 7, 2017
Registry last updated
Aug 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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