Optimizing the Assessment of Refractive Outcomes After Cataract Surgery

Not Applicable

Completed

• Conditions: Cataract
• Interventions: Procedure: Manifest refraction; Device: ACRYSOF® IQ Monofocal IOL Model SN60WF; Device: Topcon® KR-1W Wave-Front Analyzer

• Registration Number: NCT02842151
• Lead Sponsor: Alcon Research

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2016-07-14
• Study First Submitted QC: 2016-07-20
• Study First Posted: 2016-07-22
• Study Start: 2016-09-21
• Primary Completion: 2017-11-16
• Study Completion: 2017-11-16
• Status Verified: 2018-11
• Results First Submitted: 2018-11-12
• Results First Submitted QC: 2018-12-19
• Last Update Submitted: 2018-12-19
• Results First Posted: 2019-01-08
• Last Update Posted: 2019-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

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);
• Other protocol-defined inclusion criteria may apply.

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;
• Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Manifest refraction	Topcon® KR-1W Wave-Front Analyzer	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.
Manifest refraction	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.
Manifest refraction	ACRYSOF® IQ Monofocal IOL Model SN60WF	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.

Primary Outcome Measures

Name	Time	Method
IOL A-constant at 3 Months at Each Site	Month 3 (Day 80-100) Post Study Eye Implantation	The A-constant, is a type of IOL constant, that accounts for clinical variables that may affect the refractive outcome (e.g. patient factors, biometry method). It relates the power of the IOL to axial length and corneal measurements. It is specific to the design of the IOL, style, and placement within the eye. The optimization of the A-constant is fundamental to achieving the targeted refractive outcomes, offset any observed error and for ensuring high patient satisfaction following cataract surgery. Since errors/noise from refraction plays a significant role in A-constant optimization, it is important to determine if an automated method has any advantages over conventional manifest refraction. A-constants based on autorefraction and manifest refraction for the study eye are compared for each subject. The mean difference between the two methods cannot be greater than 0.15 D at each of the three study centers for the methods to be considered equivalent.