- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03350503
AcrySof IQ Toric A-Code Post-Market Clinical Study
January 10, 2022 updated by: Alcon Research
The purpose of this study is to clinically confirm the rotational stability of a modified AcrySof IQ toric intraocular lens (IOL) in a Japanese population.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Patients will be examined pre-operatively to up to 3 years post-operatively. One eligible eye will be selected as a target eye for efficacy analysis. If both eyes are eligible, the eye in which the IOL is implanted first will be selected as the target eye.
An interim analysis of results through Visit 4 (Day 120-180) is provided.
Study Type
Interventional
Enrollment (Actual)
125
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Hiroshima Prefecture
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Hiroshima, Hiroshima Prefecture, Japan, 733-0842
- Alcon Investigative Site
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Hokkaido
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Hakodate, Hokkaido, Japan, 040-0053
- Alcon Investigative Site
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Miyazaki Prefecture
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Miyakonojō, Miyazaki Prefecture, Japan, 885-0051
- Alcon Investigative Site
-
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Saga Prefecture
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Saga, Saga Prefecture, Japan, 840-0831
- Alcon Investigative Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of cataracts with planned cataract removal by phacoemulsification
- Calculated lens power within the available range
- Able to sign informed consent and complete all study visits
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Eye conditions as specified in the protocol
- Uncontrolled glaucoma
- Pregnancy, current or planned
- Other protocol-defined exclusion criteria may apply.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Acrysof IQ Toric A-code IOL
IOL implanted during cataract surgery
|
Intended to provide visual acuity, including astigmatism correction, over the lifetime of the cataract patient
Other Names:
Removal of cataractous lens and implantation of IOL
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Absolute Intraocular (IOL) Rotation (Visit 00 to Visit 4)
Time Frame: Visit 00 (Day 1 operative), Visit 4 (Day 120-180 postoperative)
|
IOL rotation was defined as the IOL axis difference between study visits.
A photograph of the eye was taken, and IOL rotation was calculated as the angle between the toric mark on the IOL at Visit 4 and the reference point from Visit 00 (minimum 0 degrees, maximum 180 degrees).
A lower value indicates greater IOL stability.
No confirmatory hypothesis testing was conducted.
|
Visit 00 (Day 1 operative), Visit 4 (Day 120-180 postoperative)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Expert Clinical Project Lead, CDMA Surgical, Alcon Research, LLC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 30, 2018
Primary Completion (Actual)
May 23, 2019
Study Completion (Actual)
December 17, 2021
Study Registration Dates
First Submitted
November 16, 2017
First Submitted That Met QC Criteria
November 17, 2017
First Posted (Actual)
November 22, 2017
Study Record Updates
Last Update Posted (Actual)
January 19, 2022
Last Update Submitted That Met QC Criteria
January 10, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ILV814-P001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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