ClinicalTrials.gg
CompletedNCT03364972Updated Aug 6, 2019

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

An interventional study of Cataract surgery in Cataract Extraction, Phacoemulsification and Glistenings, sponsored by Guy's and St Thomas' NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-06.

Sponsored by Guy's and St Thomas' NHS Foundation Trust · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
145
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 23 studies in Patient Satisfaction with a site in United Kingdom — 5 open to participants now, 5 under way, none of them phase 3. Patient Satisfaction · United Kingdom.

Started
2018
with 4 others
No phase
8 of 23
1 open now
Registered
4th of 23
by date
Lead sponsor
2 of 23
Guy's and St Thomas' NHS Foundation Trust

Among the 23 studies in Patient Satisfaction with a site in United Kingdom, this one is one of 5 that started in 2018, is one of 8 with no phase, and was the 4th registered.

Patient Satisfaction

877 studies on the registry are indexed under Patient Satisfaction; 202 are open to participants now.

Browse Patient Satisfaction studies →

Open to participants now

5 of the 23 studies in Patient Satisfaction with a site in United Kingdom are open now. Recruiting first, the newest first:

All 5 open studies →

A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →

Who these studies take

Of the 99 Patient Satisfaction studies recruiting now, 61 (62%) set no upper age limit and 30 (30%) stop at 75 or younger; 14 take children under 18; 26 take healthy volunteers.

This study: 18 Years to 100 Years · all sexes · healthy volunteers too.

The full table on the hub →

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02

Study 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.

03

Conditions studied

  • 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
04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • bilateral cataracts
  • good visual potential
  • ability to understand 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

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 , cerebrovascular events or other vaso-occlusive disease
  • already enrolled in another study
  • Exclusion criteria relate to clinical 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
145 participants (actual)

Study arms

  • Experimental
    Experimental intraocular lens implant

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

    Device: Cataract surgery

  • Active comparator
    Standard intraocular lens implant

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

    Device: Cataract surgery

Interventions

  • DeviceCataract surgery

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

06

What researchers measure

Primary outcomes

  1. Visual acuity

    As measured by conventional LogMAR visual acuity charts

    Time frame: 13 months

Secondary outcomes

  1. Incidence of intraocular lens glistenings

    Incidence of presence of intraocular lens glistenings in each study arm

    Time frame: 13 months

  2. Severity of intraocular lens glistenings

    Number of vacuoles per square millimetre

    Time frame: 13 months

  3. 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

    Time frame: 13 months

Other outcomes

  1. 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.

    Time frame: 13 months

  2. 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.

    Time frame: 13 months

  3. Patient satisfaction

    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

  4. 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).

    Time frame: 13 months

07

Study locations

1 site
  • St Thomas' Hospital NHS Trust
    London, SE1 7EH, United Kingdom
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2018 to primary completion in Aug 2019, 17 months.

Of 368 non-industry interventional studies with no phase under Patient Satisfaction, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's 17 months is above that.

Counting every sponsor, half of 370 studies reached it within 12 months; a quarter within 6 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 21, 2017
First posted
Dec 7, 2017
StartActual
Feb 6, 2018
Primary completionActual
Aug 1, 2019
CompletionActual
Aug 1, 2019
Last update
Aug 6, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 6, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03364972
Collaborators
City, University of London, King's College London
Responsible party
Sponsor
First posted
Dec 7, 2017
Start date
Feb 6, 2018
Primary completion
Aug 1, 2019
Completion
Aug 1, 2019
Last update
Aug 6, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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