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Trial record 37 of 39 for:    Recruiting, Not yet recruiting, Available Studies | "Lenses, Intraocular"

AcrySof Toric IQ Post-Market Clinical Study

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ClinicalTrials.gov Identifier: NCT03350503
Recruitment Status : Recruiting
First Posted : November 22, 2017
Last Update Posted : February 21, 2018
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cataract Astigmatism Device: AcrySof IQ Toric A-code IOL Procedure: Cataract surgery Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: AcrySof Toric IQ A-Code Post-Market Clinical Study
Actual Study Start Date : January 30, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Experimental: Acrysof IQ Toric A-code IOL
IOL implanted during cataract surgery
Device: AcrySof IQ Toric A-code IOL
Intended to provide visual acuity, including astigmatism correction, over the lifetime of the cataract patient
Other Name: Models SN6AT3, SN6AT4, SN6AT5

Procedure: Cataract surgery
Removal of cataractous lens and implantation of IOL




Primary Outcome Measures :
  1. Percentage of patients with absolute value of IOL rotation of less than 10 degrees at Visit 4 from Visit 00 [ Time Frame: Visit 00 (Day 1 operative), Visit 4 (Day 120-180 postoperative) ]
    IOL rotation is defined as the IOL axis difference between study visits. A photograph of the eye will be taken, and IOL rotation will be 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.

  2. Percentage of patients with absolute value of IOL rotation of less than 20 degrees at Visit 4 from Visit 00 [ Time Frame: Visit 00 (Day 1 operative), Visit 4 (Day 120-180 postoperative) ]
  3. Percentage of patients with absolute value of IOL rotation of less than 30 degrees at Visit 4 from Visit 00 [ Time Frame: Visit 00 (Day 1 operative), Visit 4 (Day 120-180 postoperative) ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT03350503


Contacts
Contact: Alcon Japan, Ltd. +81.3.6899.5061 alcon.medinfo@alcon.com

Locations
Japan
Alcon Investigative Site Recruiting
Hiroshima, Hiroshima Prefecture, Japan, 733-0842
Alcon Investigative Site Recruiting
Hakodate, Hokkaido, Japan, 040-0053
Alcon Investigative Site Recruiting
Miyakonojō, Miyazaki Prefecture, Japan, 885-0051
Alcon Investigative Site Recruiting
Saga, Saga Prefecture, Japan, 840-0831
Sponsors and Collaborators
Alcon Research

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT03350503     History of Changes
Other Study ID Numbers: ILV814-P001
First Posted: November 22, 2017    Key Record Dates
Last Update Posted: February 21, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Alcon Research:
phacoemulsification
intraocular lens
vision
toric

Additional relevant MeSH terms:
Cataract
Astigmatism
Lens Diseases
Eye Diseases
Refractive Errors