Optimizing the Assessment of Refractive Outcomes After Cataract Surgery

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-21

Study Completion Date

2017-11-16

Brief Summary

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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.

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Detailed Description

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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

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Cataract

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Manifest refraction

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.

Group Type OTHER

Manifest refraction

Intervention Type PROCEDURE

Manifest refraction performed by autorefraction (automated) and manual procedures (standard)

ACRYSOF® IQ Monofocal IOL Model SN60WF

Intervention Type DEVICE

Monofocal IOL implanted for long-term use over the lifetime of the cataract patient

Topcon® KR-1W Wave-Front Analyzer

Intervention Type DEVICE

Wavefront and topography system used to obtain autorefraction data

Interventions

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Manifest refraction

Manifest refraction performed by autorefraction (automated) and manual procedures (standard)

Intervention Type PROCEDURE

ACRYSOF® IQ Monofocal IOL Model SN60WF

Monofocal IOL implanted for long-term use over the lifetime of the cataract patient

Intervention Type DEVICE

Topcon® KR-1W Wave-Front Analyzer

Wavefront and topography system used to obtain autorefraction data

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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);

Exclusion Criteria

* 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;

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No