Optimizing the Assessment of Refractive Outcomes After Cataract Surgery

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02842151
• Other study ID #: ILQ732-I001
• Status: Completed
• Phase: N/A
• Start date: September 21, 2016
• Est. completion date: November 16, 2017

Study information

• Verified date: November 2018
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: November 16, 2017
• Est. primary completion date: November 16, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Capsule Opacification
• Cataract

Intervention

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
• Topcon® KR-1W Wave-Front Analyzer
Wavefront and topography system used to obtain autorefraction data

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Results from the Novartis Clinical Trial Results Website