NCT04542525

Brief Summary

The purpose of this study is to evaluate the effectiveness and safety of the TFNT20 low cylinder power intraocular lens when implanted in the eye to replace the natural lens following cataract removal.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

September 3, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 9, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2021

Completed
1 year until next milestone

Results Posted

Study results publicly available

August 17, 2022

Completed
Last Updated

August 17, 2022

Status Verified

July 1, 2022

Enrollment Period

8 months

First QC Date

September 3, 2020

Results QC Date

July 22, 2022

Last Update Submit

July 22, 2022

Conditions

AphakiaCorneal Astigmatism

Keywords

CataractIntraocular lensAstigmatismToric

Outcome Measures

Primary Outcomes (1)

  • Percentage of Eyes With ≤ 0.25 Diopter (D) Absolute Refractive Cylinder at Visit 3/3A (Day 30-60)

    A manifest refraction (manual vision test) was conducted using charts. Refractive cylinder is the amount of power in diopters that is needed to correct any remaining astigmatism.

    Day 30-60 postoperative

Secondary Outcomes (2)

  • Percentage of Eyes With ≤ 0.5 Diopter (D) Absolute Refractive Cylinder at Visit 3/3A (Day 30-60)

    Day 30-60 postoperative

  • Average Absolute Manifest Refractive Cylinder at Visit 3/3A (Day 30-60)

    Day 30-60 postoperative

Study Arms (1)

PanOptix Toric Trifocal IOL

EXPERIMENTAL

ACRYSOF IQ PanOptix Toric Trifocal IOL Model TFNT20 implanted in the capsular bag in the posterior chamber following cataract surgery. At least one eye will be implanted.

Device: ACRYSOF IQ PanOptix Toric Trifocal IOLProcedure: Cataract surgery

Interventions

ACRYSOF IQ PanOptix Toric Trifocal IOLDEVICE

Single-piece, ultraviolet and blue-light filtering, foldable, multifocal toric IOL intended to provide vision to aphakic subjects at near, intermediate, and distance and to correct pre-existing corneal astigmatism

Also known as: PanOptix Toric Trifocal IOL, Model TFNT20
PanOptix Toric Trifocal IOL
Cataract surgeryPROCEDURE

Cataract extraction by phacoemulsification, followed by implantation of the IOL per investigator's standard of care and instructions for use

PanOptix Toric Trifocal IOL

Eligibility Criteria

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

You may qualify if:

  • Eligible to be implanted with AcrySof IQ PanOptix Toric Intraocular Lens Model TFNT20 in at least one eye.
  • Potential postoperative Best Corrected Distance Visual Acuity (BCDVA) of 0.5 decimal or better.

You may not qualify if:

  • Irregular corneal astigmatism.
  • History of anterior segment, posterior segment, or optic nerve pathology.
  • History of previous intraocular or corneal (refractive or trauma related) surgery.
  • Any other planned ocular surgical procedures including but not limited to limbal relaxing incision (LRI)/Astigmatic Keratotomy and laser assisted in situ keratomileusis (LASIK).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alcon Investigative Site

Chiyoda-Ku, Tokyo, 101-0061, Japan

Location

MeSH Terms

Conditions

AphakiaAstigmatismCataract

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
Director of Clinical Projects, Surgical
Organization
Alcon Research, LLC
jessie.hull@alcon.com
+1-817-909-6199

Study Officials

  • Sr. Clinical Trial Lead, CDMA Surgical

    Alcon Japan Limited

    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

September 3, 2020

First Posted

September 9, 2020

Study Start

December 1, 2020

Primary Completion

August 10, 2021

Study Completion

August 10, 2021

Last Updated

August 17, 2022

Results First Posted

August 17, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)