CataractNCT02842151

Optimizing the Assessment of Refractive Outcomes After Cataract Surgery

A study testing Manifest refraction, ACRYSOF® IQ Monofocal IOL Model SN60WF and Topcon® KR-1W Wave-Front Analyzer in people with Cataract, run by Alcon Research.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 22 years and older
Conditions the study is for: Cataract
What is being tested?: Manifest refraction, ACRYSOF® IQ Monofocal IOL Model SN60WF and Topcon® KR-1W Wave-Front Analyzer
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 162 participants
Where: No sites listed yet
Study dates: 21 Sep 2016to 16 Nov 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 22 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Able to understand and sign an Ethics Committee/Institutional Review Board approved Informed Consent;
Willing and able to attend all scheduled study visits as required per protocol;
Diagnosed with cataract in one or both eyes;
Planned cataract removal by phacoemulsification with implantation of a monofocal IOL; laser refractive procedures for incisions (primary and sideport), capsulorhexis and lens fragmentation are allowed;
Preoperative keratometric astigmatism ≤ 1.0 diopter (D);
Other protocol-defined inclusion criteria may apply.

Who cannot join

Women of childbearing potential, pregnant, or breast-feeding;
History of ocular pathology, ocular inflammation, or ocular conditions, as specified in the protocol;
Previous intraocular or corneal surgery;
Use of systemic medications that, in the opinion of the Investigator, may confound the outcome or increase the risk of complications to the subject;
Any medical condition that, in the opinion of the Investigator, may confound the results of this study, prohibit the completion of the study assessments, or increase the risk for the subject;
Other protocol-defined exclusion criteria may apply.

About this study

Official title: Optimizing the Assessment of Refractive Outcomes After Cataract Surgery and Implantation of a Monofocal IOL

The purpose of this study is to evaluate current available assessments (automated vs. manual) with which manifest refraction data and biometric variables are obtained to understand if data from an automated refractor can be utilized to optimize the A-constant as well as manual subjective refraction (ie, to a clinically insignificant difference). The A-constant is the calculated number that helps the surgeon determine which IOL should be implanted in the eye during cataract surgery.

Read the detailed description

Subjects will be implanted with ACRYSOF® IQ Monofocal IOL Model SN60WF. Standard clinical practice will be followed for pre-operative testing, IOL power estimation and IOL implantation. Only one eye will be enrolled in the study per surgeon determination. The eye will undergo both an automated and manual manifest refraction assessment at 3 months postoperative.

Conditions: Cataract
Being tested: Manifest refraction, ACRYSOF® IQ Monofocal IOL Model SN60WF, Topcon® KR-1W Wave-Front Analyzer
Keywords: Intraocular Lens (IOL)
Medical subject headings: Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Manifest refractionProcedure or surgery
Manifest refraction performed by autorefraction (automated) and manual procedures (standard)
ACRYSOF® IQ Monofocal IOL Model SN60WFDevice
Monofocal IOL implanted for long-term use over the lifetime of the cataract patient
Topcon® KR-1W Wave-Front AnalyzerDevice
Wavefront and topography system used to obtain autorefraction data

Study groups in NCT02842151
Study group	Role	What they receive
Manifest refraction	Other	Manifest refraction performed by autorefraction (automated) and manual procedures (standard). Subject implanted with ACRYSOF® IQ Monofocal IOL Model SN60WF. Autorefraction performed by Topcon® KR-1W Wave-Front Analyzer. Receives: Procedure: Manifest refraction; Device: ACRYSOF® IQ Monofocal IOL Model SN60WF; Device: Topcon® KR-1W Wave-Front Analyzer

What is being measured

The primary outcome is the main question the study is designed to answer.

IOL A-constant at 3 Months at Each Site
The A-constant, is a type of IOL constant, that accounts for clinical variables that may affect the refractive outcome (e.g. patient factors, biometry method). It relates the power of the IOL to axial length and corneal measurements. It is specific to the design of the IOL, style, and placement within the eye. The optimization of the A-constant is fundamental to achieving the targeted refractive outcomes, offset any observed error and for ensuring high patient satisfaction following cataract surgery. Since errors/noise from refraction plays a significant role in A-constant optimization, it is important to determine if an automated method has any advantages over conventional manifest refraction. A-constants based on autorefraction and manifest refraction for the study eye are compared for each subject. The mean difference between the two methods cannot be greater than 0.15 D at each of the three study centers for the methods to be considered equivalent.
Measured: Month 3 (Day 80-100) Post Study Eye Implantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Sep 201616 Nov 2017

First posted22 Jul 2016 (estimated)
Study start21 Sep 2016
Primary completion16 Nov 2017
Study completion16 Nov 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for CataractStudies of the same condition, open and under way.
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: Other
Allocation: Not applicable
Intervention model: Single group
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 162 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02842151
Sponsor's protocol ID: ILQ732-I001
Status last verified: Nov 2018
First submitted: 14 Jul 2016
Last updated: 8 Jan 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Cataract trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Optimizing the Assessment of Refractive Outcomes After Cataract Surgery and Implantation of a Monofocal IOL
ClinicalTrials.gov ID: NCT02842151
Acronym / sponsor ID: ILQ732-I001
Conditions: Cataract
Keywords: Intraocular Lens (IOL)
Study type: Interventional
Recruitment status: Completed
Enrolment: 162 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: 21 Sep 2016 (actual)
Primary completion: 16 Nov 2017 (actual)
Study completion: 16 Nov 2017 (actual)
First posted: 22 Jul 2016 (estimated)
Results: Posted 8 Jan 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: Single blind (outcomes assessor)
Number of arms: 1

Arm	Type	Receives
Manifest refraction	Other	Procedure: Manifest refraction, Device: ACRYSOF® IQ Monofocal IOL Model SN60WF, Device: Topcon® KR-1W Wave-Front AnalyzerManifest refraction performed by autorefraction (automated) and manual procedures (standard). Subject implanted with ACRYSOF® IQ Monofocal IOL Model SN60WF. Autorefraction performed by Topcon® KR-1W Wave-Front Analyzer.

Who may qualify

Ages: 22 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Able to understand and sign an Ethics Committee/Institutional Review Board approved Informed Consent;
Willing and able to attend all scheduled study visits as required per protocol;
Diagnosed with cataract in one or both eyes;
Planned cataract removal by phacoemulsification with implantation of a monofocal IOL; laser refractive procedures for incisions (primary and sideport), capsulorhexis and lens fragmentation are allowed;
Preoperative keratometric astigmatism ≤ 1.0 diopter (D);

Key exclusion criteria (6 listed)

Women of childbearing potential, pregnant, or breast-feeding;
History of ocular pathology, ocular inflammation, or ocular conditions, as specified in the protocol;
Previous intraocular or corneal surgery;
Use of systemic medications that, in the opinion of the Investigator, may confound the outcome or increase the risk of complications to the subject;
Any medical condition that, in the opinion of the Investigator, may confound the results of this study, prohibit the completion of the study assessments, or increase the risk for the subject;

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
Manifest refractionManifest refraction performed by autorefraction (automated) and manual procedures (standard)	Procedure or surgery	Manifest refraction
ACRYSOF® IQ Monofocal IOL Model SN60WFMonofocal IOL implanted for long-term use over the lifetime of the cataract patient	Device	Manifest refraction
Topcon® KR-1W Wave-Front AnalyzerWavefront and topography system used to obtain autorefraction data	Device	Manifest refraction

Primary outcome

IOL A-constant at 3 Months at Each Site
Time frame: Month 3 (Day 80-100) Post Study Eye Implantation
The A-constant, is a type of IOL constant, that accounts for clinical variables that may affect the refractive outcome (e.g. patient factors, biometry method). It relates the power of the IOL to axial length and corneal measurements. It is specific to the design of the IOL, style, and placement within the eye. The optimization of the A-constant is fundamental to achieving the targeted refractive outcomes, offset any observed error and for ensuring high patient satisfaction following cataract surgery. Since errors/noise from refraction plays a significant role in A-constant optimization, it is important to determine if an automated method has any advantages over conventional manifest refraction. A-constants based on autorefraction and manifest refraction for the study eye are compared for each subject. The mean difference between the two methods cannot be greater than 0.15 D at each of the three study centers for the methods to be considered equivalent.

Results and safety

Results posted to the registry on 8 Jan 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Overall	150	148

Primary outcome: IOL A-constant at 3 Months at Each Site

Time frame: Month 3 (Day 80-100) Post Study Eye Implantation. Mean (Standard Deviation). Unit: unitless

Measure	Manifest Refraction n = 147	Autorefraction n = 147
Study Site 1 (US)	119.23 (0.408)	119.18 (0.493)
Study Site 2 (US)	118.86 (0.601)	118.93 (0.723)
Study Site 3 (Ireland)	118.39 (3.071)	118.52 (3.137)

Manifest Refraction vs Autorefraction: Mean Difference (Final Values): 0.05 (90% CI -0.03 to 0.13)
Manifest Refraction vs Autorefraction: Mean Difference (Net): -0.07 (90% CI -0.21 to 0.07)
Manifest Refraction vs Autorefraction: Mean Difference (Net): -0.13 (90% CI -0.22 to -0.04)

Population analysed: All-Implanted Analysis Set with non-missing data

Adverse events

Time frame: IOL implantation through study completion, an average of 3 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ocular Adverse Events	4 of 150 (2.7%)	9 of 150 (6%)	0 of 150
Non-ocular Adverse Events	2 of 150 (1.3%)	0 of 150 (0%)	0 of 150

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Cataract

Active, not recruitingPhase 4
Odyssey Evaluation in Post LASIK Patients
Cataract
RecruitingPhase 4
Arcuate Incisions With Light Adjustable Lens for Astigmatism Correction in Lens Surgery
Astigmatism
Recruiting
Clinical Evaluation of a Novel Trifocal IOL
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RecruitingObservational study
Intraoperative OCT Guidance of Intraocular Surgery II
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Not yet recruitingObservational study
Postoperative Outcome Verification of Discrepant Toric IOL Calculator Recommendations After Cataract Surgery
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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.

Alcon, A Novartis Division study director

Alcon, A Novartis Division

Questions about this trial

What is this clinical trial studying?

A study testing Manifest refraction, ACRYSOF® IQ Monofocal IOL Model SN60WF and Topcon® KR-1W Wave-Front Analyzer in people with Cataract, run by Alcon Research.

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 6 inclusion and 6 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 8 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 8 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

IOL A-constant at 3 Months at Each Site (time frame: Month 3 (Day 80-100) Post Study Eye Implantation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02842151.

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 8 Jan 2019.