PseudophakiaNCT02450799

Corrected VA With Long-Term Follow-Up After AcrySof® Intraocular Lens (IOL) Implantation

A study testing Acrylic IOL, Silicone IOL and PMMA IOL in people with Pseudophakia, run by Alcon, a Novartis Company.

Completed

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

Trial summary

The purpose of this study is to compare the long-term visual acuity (VA) with an acrylic IOL to a silicone or polymethylmethacrylate (PMMA) IOL in cataract patients. This study will take place in Japan. Read more about this study

Who is it for?: Any age
Conditions the study is for: Pseudophakia
What is being tested?: Acrylic IOL, Silicone IOL and PMMA IOL
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 104 participants
Where: No sites listed yet
Study dates: Jun 2015to May 2016
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Willing to provide voluntary consent and able to comprehend and sign the informed consent form;
Pseudophakic patients implanted with an Acrylic (AcrySof®), PMMA or silicone IOL from 1994 to 2000;
Clear intraocular media in study eye;
Best-corrected visual acuity (decimal) within 3 months post-implantation of 0.8 (decimal VA chart) or more in study eye;
No ocular or systemic condition which may affect visual acuity in study eye;
Other protocol-specified inclusion criteria may apply.

Who cannot join

Complications that may impact visual acuity in study eye at the time of the prospective visit, such as glaucoma, diabetic retinitis, ocular inflammatory disease, retinal detachment, and others as specified in the protocol;
Previous refractive surgery in study eye;
Previous IOL exchange in study eye;
Other protocol-specified exclusion criteria may apply.

About this study

Official title: Corrected VA With Long-Term Follow-Up After AcrySof® IOL Implantation

Conditions: Pseudophakia
Being tested: Acrylic IOL, Silicone IOL, PMMA IOL
Medical subject headings: Pseudophakia

What participants receive

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

Acrylic IOLDevice
Also called AcrySof® Model MA30BA, AcrySof® Model MA60BM
Acrylic IOL for long-term implantation in the cataract patient
Silicone IOLDevice
Silicone IOL for long-term implantation in the cataract patient
PMMA IOLDevice
Polymethylmethacrylate IOL for long-term implantation in the cataract patient

Study groups in NCT02450799
Study group	Role	What they receive
AcrySof IOL	Experimental	Acrylic IOL, prior implantation (1994-2000) in one or both eyes Receives: Device: Acrylic IOL
Silicone IOL	Active comparator	Silicone IOL, prior implantation (1994-2000) in one or both eyes Receives: Device: Silicone IOL
PMMA IOL	Active comparator	PMMA IOL, prior implantation (1994-2000) in one or both eyes Receives: Device: PMMA IOL

What is being measured

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

Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at the Long-Term, Post-Implantation Visit
Measurement of best corrected (with spectacles or other visual corrective devices) visual acuity (at both near and distance). Visual Acuity (VA) is measured in logMAR (logarithm of the minimum angle of resolution). A lower logMAR value indicates better visual acuity. One eye (study eye) contributed to the analysis.
Measured: Baseline (up to and including 3 months after implantation), long-term post-implantation visit (14-20 years after implantation)

Timeline

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

Jun 2015May 2016

First posted21 May 2015 (estimated)
Study startJun 2015
Primary completionMay 2016
Study completionMay 2016

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 PseudophakiaStudies 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
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 104 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02450799
Sponsor's protocol ID: ILQ245-P001
Other IDs: UMIN000017727
Status last verified: Oct 2016
First submitted: 19 May 2015
Last updated: 9 Dec 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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

RecruitingObservational study
Clinical Evaluation of Low Contrast Visual Performance and Low Light Phenomena in Patients With Various Intraocular Lens Implants
Dysphotopsia, Posterior Capsule Opacification
Not yet recruitingObservational study
IOL Position and Refractive Change After Nd:YAG Laser Posterior Capsulotomy
Posterior Capsule Opacification, Pseudophakia
Enrolling by invitation
Treatment of Residual Myopic Refraction After 6 Months on Pseudophakic Patients Using Relex-Smile
Pseudophakia, Myopia
Active, not recruiting
Treatment of Residual Hypermetropic Refraction on Pseudophakic Patients Using Allogenic Fresh Myopic Lenticule
Pseudophakia, Hypermetropia
Enrolling by invitation
Treatment of Residual Refraction Errors 6 Months After Trifocal IOL Implantation With Relex-Smile
Pseudophakia, Myopia

All Pseudophakia trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Corrected VA With Long-Term Follow-Up After AcrySof® IOL Implantation
ClinicalTrials.gov ID: NCT02450799
Acronym / sponsor ID: ILQ245-P001
Conditions: Pseudophakia
Study type: Interventional
Recruitment status: Completed
Enrolment: 104 participants (actual)
Lead sponsor: Alcon, a Novartis CompanyIndustry (pharma, biotech, devices)
Study start: Jun 2015
Primary completion: May 2016 (actual)
Study completion: May 2016 (actual)
First posted: 21 May 2015 (estimated)
Results: Posted 9 Dec 2016

Clinical summary

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

Study design

Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
AcrySof IOL	Experimental	Device: Acrylic IOLAcrylic IOL, prior implantation (1994-2000) in one or both eyes
Silicone IOL	Active comparator	Device: Silicone IOLSilicone IOL, prior implantation (1994-2000) in one or both eyes
PMMA IOL	Active comparator	Device: PMMA IOLPMMA IOL, prior implantation (1994-2000) in one or both eyes

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (6 listed)

Willing to provide voluntary consent and able to comprehend and sign the informed consent form;
Pseudophakic patients implanted with an Acrylic (AcrySof®), PMMA or silicone IOL from 1994 to 2000;
Clear intraocular media in study eye;
Best-corrected visual acuity (decimal) within 3 months post-implantation of 0.8 (decimal VA chart) or more in study eye;
No ocular or systemic condition which may affect visual acuity in study eye;

Key exclusion criteria (4 listed)

Complications that may impact visual acuity in study eye at the time of the prospective visit, such as glaucoma, diabetic retinitis, ocular inflammatory disease, retinal detachment, and others as specified in the protocol;
Previous refractive surgery in study eye;
Previous IOL exchange in study eye;
Other protocol-specified exclusion criteria may apply.

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
Acrylic IOLAlso: AcrySof® Model MA30BA, AcrySof® Model MA60BMAcrylic IOL for long-term implantation in the cataract patient	Device	AcrySof IOL
Silicone IOLSilicone IOL for long-term implantation in the cataract patient	Device	Silicone IOL
PMMA IOLPolymethylmethacrylate IOL for long-term implantation in the cataract patient	Device	PMMA IOL

Primary outcome

Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at the Long-Term, Post-Implantation Visit
Time frame: Baseline (up to and including 3 months after implantation), long-term post-implantation visit (14-20 years after implantation)
Measurement of best corrected (with spectacles or other visual corrective devices) visual acuity (at both near and distance). Visual Acuity (VA) is measured in logMAR (logarithm of the minimum angle of resolution). A lower logMAR value indicates better visual acuity. One eye (study eye) contributed to the analysis.

Results and safety

Results posted to the registry on 9 Dec 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AcrySof	31	31
Silicone	37	37
PMMA	30	30

Primary outcome: Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at the Long-Term, Post-Implantation Visit

Time frame: Baseline (up to and including 3 months after implantation), long-term post-implantation visit (14-20 years after implantation). Mean (Standard Deviation). Unit: logMAR

Measure	AcrySof n = 31	Silicone n = 37	PMMA n = 30
Baseline	-0.06 (0.07)	-0.09 (0.07)	-0.07 (0.08)
Change from baseline	0.01 (0.08)	0.04 (0.06)	-0.01 (0.05)

Population analysed: This analysis population includes all subjects who used the study devices and have data after implantation of study devices (Full Analysis Set).

Adverse events

Time frame: Adverse events (AEs) were collected for the duration of a subject's participation in the study; retrospectively 14 to 20 years and prospectively for a single visit. This analysis group includes all subjects who used the study devices and underwent the long-term post-implantation visit examination. Ocular adverse events are presented for both study eye and non-study eye combined.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AcrySof (Retrospective)	0 of 31 (0%)	0 of 31 (0%)	Not reported
Silicone (Retrospective)	0 of 37 (0%)	3 of 37 (8.1%)	Not reported
PMMA (Retrospective)	0 of 30 (0%)	4 of 30 (13.3%)	Not reported
AcrySof (Prospective)	0 of 31 (0%)	0 of 31 (0%)	Not reported
Silicone (Prospective)	0 of 37 (0%)	0 of 37 (0%)	Not reported
PMMA (Prospective)	0 of 30 (0%)	0 of 30 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Pseudophakia

RecruitingObservational study
Clinical Evaluation of Low Contrast Visual Performance and Low Light Phenomena in Patients With Various Intraocular Lens Implants
Dysphotopsia, Posterior Capsule Opacification
Not yet recruitingObservational study
IOL Position and Refractive Change After Nd:YAG Laser Posterior Capsulotomy
Posterior Capsule Opacification, Pseudophakia
Enrolling by invitation
Treatment of Residual Myopic Refraction After 6 Months on Pseudophakic Patients Using Relex-Smile
Pseudophakia, Myopia
Active, not recruiting
Treatment of Residual Hypermetropic Refraction on Pseudophakic Patients Using Allogenic Fresh Myopic Lenticule
Pseudophakia, Hypermetropia
Enrolling by invitation
Treatment of Residual Refraction Errors 6 Months After Trifocal IOL Implantation With Relex-Smile
Pseudophakia, Myopia

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.

Group Manager, Clinical Dev. study director

Alcon Japan, Ltd.

Questions about this trial

What is this clinical trial studying?

A study testing Acrylic IOL, Silicone IOL and PMMA IOL in people with Pseudophakia, run by Alcon, a Novartis Company.

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 4 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 9 Dec 2016. 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 9 Dec 2016). 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?

Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at the Long-Term, Post-Implantation Visit (time frame: Baseline (up to and including 3 months after implantation), long-term post-implantation visit (14-20 years after 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 NCT02450799.

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 9 Dec 2016.