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

Primary Purpose

Cataract Extraction, Phacoemulsification, Glistenings

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Cataract surgery
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 Extraction focused on measuring cataract, cataract extraction, interocular lens implant, glistenings, phacoemulsification, hydrophobic acrylic, light scatter, patient related outcome measures

Eligibility Criteria

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

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

Sites / Locations

  • St Thomas' Hospital NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental intraocular lens implant

Standard intraocular lens implant

Arm Description

'Alcon Clareon' : New monofocal, hydrophobic acrylic intraocular lens implant

Abbott Tecnis PCB00- Standard monofocal,hydrophobic acrylic intraocular lens implant

Outcomes

Primary Outcome Measures

Visual acuity
As measured by conventional LogMAR visual acuity charts

Secondary Outcome Measures

Incidence of intraocular lens glistenings
Incidence of presence of intraocular lens glistenings in each study arm
Severity of intraocular lens glistenings
Number of vacuoles per square millimetre
Refraction (i.e. glasses prescription)
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

Full Information

First Posted
November 21, 2017
Last Updated
August 5, 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
NCT03364972
Brief Title
A Study Comparing Two Monofocal, Aspheric, Hydrophobic Acrylic Intraocular Lenses: the Alcon CLAREON® and the Abbott Medical Optics PCB00
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
February 6, 2018 (Actual)
Primary Completion Date
August 1, 2019 (Actual)
Study Completion Date
August 1, 2019 (Actual)

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

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract Extraction, Phacoemulsification, Glistenings, Intraocular Lens Implant, Hydrophobic Acrylic, Cataract Surgery, Light Scatter, Patient Satisfaction, Patient Related Outcome Measures
Keywords
cataract, cataract extraction, interocular lens implant, glistenings, phacoemulsification, hydrophobic acrylic, light scatter, patient related outcome measures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
145 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental intraocular lens implant
Arm Type
Experimental
Arm Description
'Alcon Clareon' : New monofocal, hydrophobic acrylic intraocular lens implant
Arm Title
Standard intraocular lens implant
Arm Type
Active Comparator
Arm Description
Abbott Tecnis PCB00- Standard monofocal,hydrophobic acrylic intraocular lens implant
Intervention Type
Device
Intervention Name(s)
Cataract surgery
Intervention Description
Conventional small-incision phacoemulsification cataract surgery with insertion of intraocular lens implant
Primary Outcome Measure Information:
Title
Visual acuity
Description
As measured by conventional LogMAR visual acuity charts
Time Frame
13 months
Secondary Outcome Measure Information:
Title
Incidence of intraocular lens glistenings
Description
Incidence of presence of intraocular lens glistenings in each study arm
Time Frame
13 months
Title
Severity of intraocular lens glistenings
Description
Number of vacuoles per square millimetre
Time Frame
13 months
Title
Refraction (i.e. glasses prescription)
Description
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
Time Frame
13 months
Other Pre-specified Outcome Measures:
Title
Forward light scatter
Description
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.
Time Frame
13 months
Title
Contrast sensitivity
Description
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.
Time Frame
13 months
Title
Patient satisfaction
Description
Validated patient satisfaction questionnaire. We use specially designed and validated conversion tables to convert raw scores from questionnaires to Rasch calibrated measures.
Time Frame
13 months
Title
Self-reported health
Description
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).
Time Frame
13 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 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
Facility Information:
Facility Name
St Thomas' Hospital NHS Trust
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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