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

Sponsor
Guy's and St Thomas' NHS Foundation Trust (Other)
Overall Status
Completed
CT.gov ID
NCT03364972
Collaborator
City, University of London (Other), King's College London (Other)
145
Enrollment
1
Location
2
Arms
17.8
Actual Duration (Months)
8.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Cataract surgery
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
145 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Feb 6, 2018
Actual Primary Completion Date :
Aug 1, 2019
Actual Study Completion Date :
Aug 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Visual acuity [13 months]

    As measured by conventional LogMAR visual acuity charts

Secondary Outcome Measures

  1. Incidence of intraocular lens glistenings [13 months]

    Incidence of presence of intraocular lens glistenings in each study arm

  2. Severity of intraocular lens glistenings [13 months]

    Number of vacuoles per square millimetre

  3. Refraction (i.e. glasses prescription) [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 Outcome Measures

  1. Forward light scatter [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 [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 [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 [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 St Thomas' Hospital NHS Trust London United Kingdom SE1 7EH

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT03364972
Other Study ID Numbers:
  • 232017
First Posted:
Dec 7, 2017
Last Update Posted:
Aug 6, 2019
Last Verified:
Aug 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Guy's and St Thomas' NHS Foundation Trust
cataract
cataract extraction
interocular lens implant
glistenings
phacoemulsification
hydrophobic acrylic
light scatter
patient related outcome measures
Additional relevant MeSH terms:
Cataract

Study Results

No Results Posted as of Aug 6, 2019