Cataract ExtractionNCT03364972
A Study Comparing Two Monofocal, Aspheric, Hydrophobic Acrylic Intraocular Lenses: the Alcon CLAREON® and the Abbott Medical Optics PCB00
A study testing Cataract surgery in people with Cataract Extraction and Phacoemulsification, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Cataract Extraction, Phacoemulsification, Glistenings
- What is being tested?
- Cataract surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Feb 2018to 1 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- age-related macula degeneration
- glaucoma
- previous retinal vascular disorders
- previous retinal detachment or tear
- any neuro-ophthalmological condition
- any inherited retinal disorder or pathology
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Cataract Extraction, Phacoemulsification, Glistenings, Intraocular Lens Implant, Hydrophobic Acrylic, Cataract Surgery
- Being tested
- Cataract surgery
- Keywords
- cataract, cataract extraction, interocular lens implant, glistenings, phacoemulsification, hydrophobic acrylic, light scatter, patient related outcome measures
- Medical subject headings
- Patient Satisfaction, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cataract surgeryDevice
Conventional small-incision phacoemulsification cataract surgery with insertion of intraocular lens implant
| Study group | Role | What they receive |
|---|---|---|
| Experimental intraocular lens implant | Experimental | 'Alcon Clareon' : New monofocal, hydrophobic acrylic intraocular lens implant Receives: Device: Cataract surgery |
| Standard intraocular lens implant | Active comparator | Abbott Tecnis PCB00- Standard monofocal,hydrophobic acrylic intraocular lens implant Receives: Device: Cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
As measured by conventional LogMAR visual acuity charts
Measured: 13 months
Secondary outcomes (3)
Incidence of intraocular lens glistenings
Incidence of presence of intraocular lens glistenings in each study arm
Measured: 13 months
Severity of intraocular lens glistenings
Number of vacuoles per square millimetre
Measured: 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
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2017
- Study start6 Feb 2018
- Primary completion1 Aug 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract ExtractionStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- City, University of London, King's College London
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03364972
- Sponsor's protocol ID
- 232017
- Status last verified
- Aug 2019
- First submitted
- 21 Nov 2017
- Last updated
- 6 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03364972
- Acronym / sponsor ID
- 232017
- Conditions
- Cataract Extraction, Phacoemulsification, Glistenings, Intraocular Lens Implant, Hydrophobic Acrylic, Cataract Surgery
- Keywords
- cataract, cataract extraction, interocular lens implant, glistenings, phacoemulsification, hydrophobic acrylic, light scatter, patient related outcome measures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- City, University of London, King's College London
- Study start
- 6 Feb 2018 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 7 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental intraocular lens implant | Experimental | Device: Cataract surgery'Alcon Clareon' : New monofocal, hydrophobic acrylic intraocular lens implant |
| Standard intraocular lens implant | Active comparator | Device: Cataract surgeryAbbott Tecnis PCB00- Standard monofocal,hydrophobic acrylic intraocular lens implant |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- bilateral cataracts
- good visual potential
- ability to understand informed consent and objectives of the trial
- not-pregnant
- not breast feeding
Key exclusion criteria (13 listed)
- age-related macula degeneration
- glaucoma
- previous retinal vascular disorders
- previous retinal detachment or tear
- any neuro-ophthalmological condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cataract surgeryConventional small-incision phacoemulsification cataract surgery with insertion of intraocular lens implant | Device | Experimental intraocular lens implant, Standard intraocular lens implant |
Primary outcome
Visual acuity
Time frame: 13 months
As measured by conventional LogMAR visual acuity charts
3 secondary outcomes
Incidence of intraocular lens glistenings
Time frame: 13 months
Severity of intraocular lens glistenings
Time frame: 13 months
Refraction (i.e. glasses prescription)
Time frame: 13 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cataract surgery in people with Cataract Extraction and Phacoemulsification, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity (time frame: 13 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2019.