NCT03090256

Brief Summary

The purpose of this study is to evaluate the effectiveness and safety of the AcrySof® IQ PanOptix™ Intraocular Lens (IOL) Model TFNT00 when implanted 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
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 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

March 20, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 24, 2017

Completed
18 days until next milestone

Study Start

First participant enrolled

April 11, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2018

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

September 24, 2019

Completed
Last Updated

September 24, 2019

Status Verified

August 1, 2019

Enrollment Period

10 months

First QC Date

March 20, 2017

Results QC Date

August 30, 2019

Last Update Submit

August 30, 2019

Conditions

Cataract

Keywords

Trifocal IOL

Outcome Measures

Primary Outcomes (3)

  • Monocular Photopic Best Corrected Distance Visual Acuity (5 m)

    Visual acuity (VA) was tested monocularly (each eye separately) under well-lit conditions with the subject's best spectacle correction at a distance of 5 meters (m) using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. No hypothesis testing was planned for this study.

    Visit 0 preoperative, Visit 1/1A (Day 1-2), Visit 2/2A (Day 7-14), Visit 3/3A (Day 30-60), Visit 4A (Day 120-180) post second implantation

  • Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm)

    VA was tested monocularly under well-lit conditions using a chart. Distance-corrected VA at 60 cm is the VA at 60 cm measured under a corrected condition in which best-corrected VA at 5 m was obtained. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. No hypothesis testing was planned for this study.

    Visit 0 preoperative, Visit 1/1A (Day 1-2), Visit 2/2A (Day 7-14), Visit 3/3A (Day 30-60), Visit 4A (Day 120-180) post second implantation

  • Monocular Photopic Distance Corrected Near Visual Acuity (40 cm)

    VA was tested monocularly under well-lit conditions using a chart. Distance-corrected VA at 40 cm is the VA at 40 cm measured under a corrected condition in which best-corrected VA at 5 m was obtained. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. No hypothesis testing was planned for this study.

    Visit 0 preoperative, Visit 1/1A (Day 1-2), Visit 2/2A (Day 7-14), Visit 3/3A (Day 30-60), Visit 4A (Day 120-180) post second implantation

Study Arms (1)

PanOptix IOL

EXPERIMENTAL

AcrySof® IQ PanOptix™ IOL, bilateral implantation

Device: AcrySof® IQ PanOptix™ IOL

Interventions

AcrySof® IQ PanOptix™ IOLDEVICE

Multifocal intraocular lens (IOL) (near, intermediate, distance) implanted for long-term use over the lifetime of the cataract patient

Also known as: Model TFNT00
PanOptix IOL

Eligibility Criteria

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

You may qualify if:

  • Able to comprehend and sign a statement of informed consent;
  • Willing and able to complete all required postoperative visits;
  • Cataracts in both eyes with planned cataract removal by phacoemulsification;
  • Calculated lens power within the available range;
  • Potential postoperative best corrected distance visual acuity (BCDVA) of 0.5 decimal or better in both eyes;
  • Able to undergo second eye surgery within 30 days of the first eye surgery.

You may not qualify if:

  • Significant irregular corneal aberration as demonstrated by corneal topography;
  • Inflammation or edema (swelling) of the cornea affecting post-operative visual acuity;
  • Degenerative visual disorders (e.g. macular degeneration or other retinal disorders) that are predicted to cause future acuity losses;
  • Previous refractive surgery;
  • Diabetic retinopathy
  • Other eye conditions as specified in the protocol
  • Pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Alcon Investigative Site

Fukuoka, 812-0011, Japan

Location

Alcon Investigative Site

Tokyo, 101-0061, Japan

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Results Point of Contact

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

Study Officials

  • Group Manager, Clinical Development

    Alcon Japan, Ltd.

    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

March 20, 2017

First Posted

March 24, 2017

Study Start

April 11, 2017

Primary Completion

February 13, 2018

Study Completion

February 13, 2018

Last Updated

September 24, 2019

Results First Posted

September 24, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

JP(2)