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

• Sponsor: Alcon, a Novartis Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02450799
• Collaborator: (none)
• Enrollment: 104
• Arms: 3
• Duration (Months): 11

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pseudophakia	Device: Acrylic IOL; Device: Silicone IOL; Device: PMMA IOL	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 104 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Official Title: Corrected VA With Long-Term Follow-Up After AcrySof® IOL Implantation
• Study Start Date: Jun 1, 2015
• Actual Primary Completion Date: May 1, 2016
• Actual Study Completion Date: May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AcrySof IOL Acrylic IOL, prior implantation (1994-2000) in one or both eyes	Device: Acrylic IOL; Acrylic IOL for long-term implantation in the cataract patient; Other Names: AcrySof® Model MA30BA AcrySof® Model MA60BM
Active Comparator: Silicone IOL Silicone IOL, prior implantation (1994-2000) in one or both eyes	Device: Silicone IOL; Silicone IOL for long-term implantation in the cataract patient
Active Comparator: PMMA IOL PMMA IOL, prior implantation (1994-2000) in one or both eyes	Device: PMMA IOL; Polymethylmethacrylate IOL for long-term implantation in the cataract patient

Outcome Measures

Primary Outcome Measures

1. Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at the Long-Term, Post-Implantation Visit [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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.

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Alcon, a Novartis Company

Investigators

• Study Director: Group Manager, Clinical Dev., Alcon Japan, Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon, a Novartis Company
• ClinicalTrials.gov Identifier: NCT02450799
• Other Study ID Numbers: ILQ245-P001; UMIN000017727
• First Posted: May 21, 2015
• Last Update Posted: Dec 9, 2016
• Last Verified: Oct 1, 2016

• Additional relevant MeSH terms: Pseudophakia

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from 11 study centers located in Japan.
Pre-assignment Detail	Of the 104 enrolled, 6 subjects were exited as screen failures and deemed ineligible for participation. This reporting group includes all eligible subjects (98).

Arm/Group Title	AcrySof	Silicone	PMMA
Arm/Group Description	Acrylic IOL, prior implantation (1994-2000) in one or both eyes	Silicone IOL, prior implantation (1994-2000) in one or both eyes	Polymethylmethacrylate (PMMA) IOL, prior implantation (1994-2000) in one or both eyes
Period Title: Overall Study
STARTED	31	37	30
COMPLETED	31	37	30
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	AcrySof	Silicone	PMMA	Total
Arm/Group Description	Acrylic IOL, prior implantation (1994-2000) in one or both eyes	Silicone IOL, prior implantation (1994-2000) in one or both eyes	Polymethylmethacrylate IOL, prior implantation (1994-2000) in one or both eyes	Total of all reporting groups
Overall Participants	31	37	30	98
Age, Customized (subjects) [Number]
<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 (Count of Participants)
Female	23 74.2%	24 64.9%	19 63.3%	66 67.3%
Male	8 25.8%	13 35.1%	11 36.7%	32 32.7%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	AcrySof	Silicone	PMMA
Arm/Group Description	Acrylic IOL, prior implantation (1994-2000) in one or both eyes	Silicone IOL, prior implantation (1994-2000) in one or both eyes	Polymethylmethacrylate IOL, prior implantation (1994-2000) in one or both eyes
Measure Participants	31	37	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)

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.
Adverse Event Reporting Description	An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, whether or not related to the investigational medical device (test/control article or procedure). AEs are reported retrospectively (onset between Baseline (defined as the period within 3 months after surgery) and Informed Consent acquisition) and prospectively (onset after Informed Consent acquisition).
Arm/Group Title	AcrySof (Retrospective)		Silicone (Retrospective)		PMMA (Retrospective)		AcrySof (Prospective)		Silicone (Prospective)		PMMA (Prospective)
Arm/Group Description	Subjects with prior implantation of acrylic IOL who experienced an AE related to decrease of BCVA in the study eye		Subjects with prior implantation of Silicone IOL who experienced an AE related to decrease of BCVA in the study eye		Subjects with prior implantation of PMMA IOL who experienced an AE related to decrease of BCVA in the study eye		Subjects with prior implantation of acrylic IOL who experienced an AE with onset after the Informed Consent acquisition		Subjects with prior implantation of Silicone IOL who experienced an AE with onset after the Informed Consent acquisition		Subjects with prior implantation of PMMA IOL who experienced an AE with onset after the Informed Consent acquisition
All Cause Mortality
	AcrySof (Retrospective)		Silicone (Retrospective)		PMMA (Retrospective)		AcrySof (Prospective)		Silicone (Prospective)		PMMA (Prospective)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	AcrySof (Retrospective)		Silicone (Retrospective)		PMMA (Retrospective)		AcrySof (Prospective)		Silicone (Prospective)		PMMA (Prospective)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/31 (0%)		0/37 (0%)		0/30 (0%)		0/31 (0%)		0/37 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	AcrySof (Retrospective)		Silicone (Retrospective)		PMMA (Retrospective)		AcrySof (Prospective)		Silicone (Prospective)		PMMA (Prospective)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/31 (0%)		3/37 (8.1%)		4/30 (13.3%)		0/31 (0%)		0/37 (0%)		0/30 (0%)
Eye disorders
posterior capsule opacification	0/31 (0%)		3/37 (8.1%)		4/30 (13.3%)		0/31 (0%)		0/37 (0%)		0/30 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Sponsor reserves the right of prior review of any publication or presentation of information related to the study.