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Optimizing the Assessment of Refractive Outcomes After Cataract Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02842151
Recruitment Status : Completed
First Posted : July 22, 2016
Results First Posted : January 8, 2019
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cataract Procedure: Manifest refraction Device: ACRYSOF® IQ Monofocal IOL Model SN60WF Device: Topcon® KR-1W Wave-Front Analyzer Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 162 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Optimizing the Assessment of Refractive Outcomes After Cataract Surgery and Implantation of a Monofocal IOL
Actual Study Start Date : September 21, 2016
Actual Primary Completion Date : November 16, 2017
Actual Study Completion Date : November 16, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. IOL A-constant at 3 Months at Each Site [ Time Frame: 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.



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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02842151


Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Alcon, A Novartis Division Alcon, A Novartis Division
  Study Documents (Full-Text)

Documents provided by Alcon Research:
Study Protocol  [PDF] June 23, 2016
Statistical Analysis Plan  [PDF] September 1, 2016

Additional Information:
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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT02842151    
Other Study ID Numbers: ILQ732-I001
First Posted: July 22, 2016    Key Record Dates
Results First Posted: January 8, 2019
Last Update Posted: January 8, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Alcon Research:
Intraocular Lens (IOL)
Additional relevant MeSH terms:
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Cataract
Capsule Opacification
Lens Diseases
Eye Diseases