CompletedNCT02450799Updated Dec 9, 2016Results posted

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

An interventional study of Acrylic IOL and Silicone IOL in Pseudophakia, sponsored by Alcon, a Novartis Company. Completed. Per ClinicalTrials.gov, last updated 2016-12-09.

Sponsored by Alcon, a Novartis Company (formerly part of Novartis) · Not applicable and Interventional

Phase: Not applicable
Study type: Interventional
Enrollment: 104
Allocation: Non-randomized
Sex: All

Study 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.

Conditions studied

Pseudophakia

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Pseudophakia 54

In context

Pseudophakia

54 studies on the registry are indexed under Pseudophakia; 8 are open to participants now.

This study's enrollment of 104 is above the median of 45 across 25 interventional studies indexed under Pseudophakia.

Browse Pseudophakia studies →

Lead sponsor

Alcon, a Novartis Company is the lead sponsor of 13 studies on the registry; none are open to participants now.

First submitted before Alcon left Novartis.

Browse Alcon studies →All Novartis studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible: All
Accepts healthy volunteers: No

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

Willing to provide voluntary consent and able to comprehend and sign the 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.

Exclusion criteria

Exclusion Criteria:

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.

Terms in these criteria, in plain language(1)

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.

Study design

Phase: Not applicable
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: Single (Outcomes assessor)
Enrollment: 104 participants (actual)

Study arms

Experimental
AcrySof IOL
Acrylic IOL, prior implantation (1994-2000) in one or both eyes
Device: Acrylic IOL
Active comparator
Silicone IOL
Silicone IOL, prior implantation (1994-2000) in one or both eyes
Device: Silicone IOL
Active comparator
PMMA IOL
PMMA IOL, prior implantation (1994-2000) in one or both eyes
Device: PMMA IOL

Interventions

DeviceAcrylic IOL
Acrylic IOL for long-term implantation in the cataract patient
Also known as: AcrySof® Model MA30BA, AcrySof® Model MA60BM
DeviceSilicone IOL
Silicone IOL for long-term implantation in the cataract patient
DevicePMMA IOL
Polymethylmethacrylate IOL for long-term implantation in the cataract patient

What researchers measure

Primary outcomes

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

Results

Posted Dec 9, 2016

Participant flow

Subjects were recruited from 11 study centers located in Japan.

Participant flow — Overall Study
Milestone	AcrySof	Silicone	PMMA
Started	31	37	30
Completed	31	37	30
Not completed	0	0	0

Outcome measures

PrimaryMean 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.

Time frame:: Baseline (up to and including 3 months after implantation), long-term post-implantation visit (14-20 years after implantation)
Reported as:: Mean · logMAR

Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at the Long-Term, Post-Implantation Visit
logMAR	AcrySof	Silicone	PMMA
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

Adverse events

Collected over 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.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
AcrySof (Retrospective)	—	0/31 (0%)	0/31 (0%)
Silicone (Retrospective)	—	0/37 (0%)	3/37 (8.1%)
PMMA (Retrospective)	—	0/30 (0%)	4/30 (13.3%)
AcrySof (Prospective)	—	0/31 (0%)	0/31 (0%)
Silicone (Prospective)	—	0/37 (0%)	0/37 (0%)
PMMA (Prospective)	—	0/30 (0%)	0/30 (0%)

Most frequent other events

Most frequent other events
Event	AcrySof (Retrospective)	Silicone (Retrospective)	PMMA (Retrospective)	AcrySof (Prospective)	Silicone (Prospective)	PMMA (Prospective)
posterior capsule opacificationEye disorders	0/31	3/37	4/30	0/31	0/37	0/30

Baseline characteristics

This analysis population includes all subjects who used the study devices and underwent the long-term post-implantation visit examination (Safety Set).

Age, Customized
Age, Customized(subjects)	AcrySof	Silicone	PMMA	Total
<70 years	2	4	6	12
≥70 and ≤79 years	13	21	11	45
≥80 and ≤89 years	12	12	9	33
>90 years	4	0	4	8

Sex: Female, Male
Sex: Female, Male(Participants)	AcrySof	Silicone	PMMA	Total
Female	23	24	19	66
Male	8	13	11	32

Study locations

No study locations are listed for this record.

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2015, a primary completion of May 2016 and a completion of May 2016. It does not say whether these dates are actual or estimated.

Results were first posted in Dec 2016, 7 months after primary completion.

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

Registered: May 19, 2015
First posted: May 21, 2015
Start: Jun 2015
Primary completionActual: May 2016
CompletionActual: May 2016
Results first posted: Dec 9, 2016
Last update: Dec 9, 2016

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 Dec 9, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02450799
Lead sponsor: Alcon, a Novartis Company
Responsible party: Sponsor
First posted: May 21, 2015
Start date: Jun 2015
Primary completion: May 2016
Completion: May 2016
Results posted: Dec 9, 2016
Last update: Dec 9, 2016

Study contacts

Group Manager, Clinical Dev.

study director · Alcon Japan, Ltd.

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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