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

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

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.

Study Overview

• Status: Completed
• Conditions: Patient Satisfaction; Cataract Extraction; Cataract Surgery; Phacoemulsification; Intraocular Lens Implant; Patient Related Outcome Measures; Glistenings; Hydrophobic Acrylic; Light Scatter
• Intervention / Treatment: Device: Cataract surgery

• Study Type: Interventional
• Enrollment (Actual): 145
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE1 7EH
    • St Thomas' Hospital NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental intraocular lens implant; 'Alcon Clareon' : New monofocal, hydrophobic acrylic intraocular lens implant	Device: Cataract surgery; Conventional small-incision phacoemulsification cataract surgery with insertion of intraocular lens implant
Active Comparator: Standard intraocular lens implant; Abbott Tecnis PCB00- Standard monofocal,hydrophobic acrylic intraocular lens implant	Device: Cataract surgery; Conventional small-incision phacoemulsification cataract surgery with insertion of intraocular lens implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual acuity	As measured by conventional LogMAR visual acuity charts	13 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of intraocular lens glistenings	Incidence of presence of intraocular lens glistenings in each study arm	13 months
Severity of intraocular lens glistenings	Number of vacuoles per square millimetre	13 months
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	13 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forward light scatter	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.	13 months
Contrast sensitivity	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.	13 months
Patient satisfaction	Validated patient satisfaction questionnaire. We use specially designed and validated conversion tables to convert raw scores from questionnaires to Rasch calibrated measures.	13 months
Self-reported health	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).	13 months

Collaborators and Investigators

• Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Collaborators: King's College London; City, University of London

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2018
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: November 21, 2017
• First Submitted That Met QC Criteria: December 6, 2017
• First Posted (Actual): December 7, 2017

Study Record Updates

• Last Update Posted (Actual): August 6, 2019
• Last Update Submitted That Met QC Criteria: August 5, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: phacoemulsification; cataract; cataract extraction; patient related outcome measures; interocular lens implant; glistenings; hydrophobic acrylic; light scatter
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: 232017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No