NCT03350503

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 22, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

January 30, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2019

Completed
12 months until next milestone

Results Posted

Study results publicly available

May 12, 2020

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2021

Completed
Last Updated

December 28, 2022

Status Verified

November 1, 2022

Enrollment Period

1.3 years

First QC Date

November 16, 2017

Results QC Date

April 21, 2020

Last Update Submit

November 28, 2022

Conditions

CataractAstigmatism

Keywords

phacoemulsificationintraocular lensvisiontoric

Outcome Measures

Primary Outcomes (1)

  • Percentage of Eyes With Absolute Value of Intraocular (IOL) Rotation (Visit 00 to Visit 4)

    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 0 operative), Visit 4 (Day 120-180 postoperative)

Other Outcomes (10)

  • Percentage of Eyes With Absolute Value of IOL Rotation From Visit 00

    Visit 00 (Day 0 operative), Visit 00-A (Day 0, 1 +/- 0.5 hours postoperative), Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140)

  • Mean Absolute Value of IOL Rotation From Visit 00

    Visit 00 (Day 0 operative), Visit 00-A (Day 0, 1 +/- 0.5 hours postoperative), Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140)

  • Mean Uncorrected Distance Visual Acuity (UCDVA) by Visit

    Visit 0 (Preoperative), Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140)

  • +7 more other outcomes

Study Arms (1)

Acrysof IQ Toric A-code IOL

EXPERIMENTAL

IOL implanted during cataract surgery

Device: AcrySof IQ Toric A-code IOLProcedure: Cataract surgery

Interventions

AcrySof IQ Toric A-code IOLDEVICE

Intended to provide visual acuity, including astigmatism correction, over the lifetime of the cataract patient

Also known as: Models SN6AT3, SN6AT4, SN6AT5
Acrysof IQ Toric A-code IOL
Cataract surgeryPROCEDURE

Removal of cataractous lens and implantation of IOL

Acrysof IQ Toric A-code IOL

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Eye conditions as specified in the protocol
  • Uncontrolled glaucoma
  • Pregnancy, current or planned

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Alcon Investigative Site

Hiroshima, Hiroshima, 733-0842, Japan

Location

Alcon Investigative Site

Hakodate, Hokkaido, 040-0053, Japan

Location

Alcon Investigative Site

Miyakonojō, Miyazaki, 885-0051, Japan

Location

Alcon Investigative Site

Saga, Saga-ken, 840-0831, Japan

Location

MeSH Terms

Conditions

CataractAstigmatism

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesRefractive Errors

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Results Point of Contact

Title
Expert Clinical Project Lead, CDMA Surgical
Organization
Alcon Research
alcon.medinfo@alcon.com
1-888-451-3937

Study Officials

  • Expert Clinical Project Lead, CDMA Surgical

    Alcon Research, LLC

    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
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2017

First Posted

November 22, 2017

Study Start

January 30, 2018

Primary Completion

May 23, 2019

Study Completion

December 17, 2021

Last Updated

December 28, 2022

Results First Posted

May 12, 2020

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

JP(4)