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

NCT ID: NCT02450799

Last Updated: 2016-12-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pseudophakia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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AcrySof IOL

Acrylic IOL, prior implantation (1994-2000) in one or both eyes

Group Type EXPERIMENTAL

Acrylic IOL

Intervention Type DEVICE

Acrylic IOL for long-term implantation in the cataract patient

Silicone IOL

Silicone IOL, prior implantation (1994-2000) in one or both eyes

Group Type ACTIVE_COMPARATOR

Silicone IOL

Intervention Type DEVICE

Silicone IOL for long-term implantation in the cataract patient

PMMA IOL

PMMA IOL, prior implantation (1994-2000) in one or both eyes

Group Type ACTIVE_COMPARATOR

PMMA IOL

Intervention Type DEVICE

Polymethylmethacrylate IOL for long-term implantation in the cataract patient

Interventions

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Acrylic IOL

Acrylic IOL for long-term implantation in the cataract patient

Intervention Type DEVICE

Silicone IOL

Silicone IOL for long-term implantation in the cataract patient

Intervention Type DEVICE

PMMA IOL

Polymethylmethacrylate IOL for long-term implantation in the cataract patient

Intervention Type DEVICE

Other Intervention Names

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AcrySof® Model MA30BA AcrySof® Model MA60BM

Eligibility Criteria

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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;

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;
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon, a Novartis Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Group Manager, Clinical Dev.

Role: STUDY_DIRECTOR

Alcon Japan, Ltd.

Countries

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Japan

Other Identifiers

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UMIN000017727

Identifier Type: OTHER

Identifier Source: secondary_id

ILQ245-P001

Identifier Type: -

Identifier Source: org_study_id