Optimizing the Assessment of Refractive Outcomes After Cataract Surgery

Optimizing the Assessment of Refractive Outcomes After Cataract Surgery and Implantation of a Monofocal IOL

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 162
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Procedure: Manifest refraction; Manifest refraction performed by autorefraction (automated) and manual procedures (standard); Device: ACRYSOF® IQ Monofocal IOL Model SN60WF; Monofocal IOL implanted for long-term use over the lifetime of the cataract patient; Device: Topcon® KR-1W Wave-Front Analyzer; Wavefront and topography system used to obtain autorefraction data

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IOL A-constant at 3 Months at Each Site	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.	Month 3 (Day 80-100) Post Study Eye Implantation

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Alcon, A Novartis Division, Alcon, A Novartis Division

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2016
• Primary Completion (Actual): November 16, 2017
• Study Completion (Actual): November 16, 2017

Study Registration Dates

• First Submitted: July 14, 2016
• First Submitted That Met QC Criteria: July 20, 2016
• First Posted (Estimate): July 22, 2016

Study Record Updates

• Last Update Posted (Actual): January 8, 2019
• Last Update Submitted That Met QC Criteria: December 19, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Intraocular Lens (IOL)
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Capsule Opacification
• Other Study ID Numbers: ILQ732-I001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No