Optimizing the Assessment of Refractive Outcomes After Cataract Surgery

NCT02842151 | Completed Results

• 1 other identifier: ILQ732-I001
• Study Type: interventional
• Target: 162
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cataract

Keywords

Intraocular Lens (IOL)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Manifest refraction

OTHER

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

Interventions

Manifest refraction PROCEDURE

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

Manifest refraction

ACRYSOF® IQ Monofocal IOL Model SN60WF DEVICE

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

Manifest refraction

Topcon® KR-1W Wave-Front Analyzer DEVICE

Wavefront and topography system used to obtain autorefraction data

Manifest refraction

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• 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;

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Results Point of Contact

• Title: Senior Global Brand Affairs Lead, CDMA Surgical
• Organization: Alcon, A Novartis Division

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Alcon, A Novartis Division

  Alcon, A Novartis Division

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2016
• First Posted: July 22, 2016
• Study Start: September 21, 2016
• Primary Completion: November 16, 2017
• Study Completion: November 16, 2017
• Last Updated: January 8, 2019
• Results First Posted: January 8, 2019

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share