Optimizing the Assessment of Refractive Outcomes After Cataract Surgery

Alcon

Status: Completed

Conditions: Cataract

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02842151

ILQ732-I001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 162 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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162 participants in 1 patient group

Manifest refraction

Other group

Description:

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.

Treatment:

Device: Topcon® KR-1W Wave-Front Analyzer

Procedure: Manifest refraction

Device: ACRYSOF® IQ Monofocal IOL Model SN60WF