NCT03085901

Brief Summary

This study is to compare the clinical outcome of Precizon toric intraocular lens(IOL) to that of Tecnis toric IOL.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2016

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

April 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 21, 2017

Completed
Last Updated

March 21, 2017

Status Verified

March 1, 2017

Enrollment Period

3 months

First QC Date

March 11, 2017

Last Update Submit

March 15, 2017

Conditions

Astigmatism

Outcome Measures

Primary Outcomes (1)

  • Postoperative refractive astigmatism

    Diopter

    postoperative 3 months

Secondary Outcomes (1)

  • Postoperative visual acuity

    postoperative 3 months

Study Arms (2)

Precizon toric intraocular lens

ACTIVE COMPARATOR

Cataract surgery and implantation of Precizon toric intraocular lens

Device: Precizon toric intraocular lens

Tecnis toric intraocular lens

ACTIVE COMPARATOR

Cataract surgery and implantation of Tecnis toric intraocular lens

Device: Tecnis toric intraocular lens

Interventions

Precizon toric intraocular lensDEVICE

Phacoemulsification and implantation of Precizon toric intraocular lens

Precizon toric intraocular lens
Tecnis toric intraocular lensDEVICE

Phacoemulsification and implantation of Tecnis toric intraocular lens

Tecnis toric intraocular lens

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with cataract and regular corneal astigmatism(between 0.50 diopter and 2.50 diopter considering both anterior and posterior corneal surface)

You may not qualify if:

  • Amblyopia, irregular astigmatism, corneal opacity, glaucoma, retinal disease, history of ocular inflammation, previous other intraocular surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Jung NY, Lim DH, Hwang SS, Hyun J, Chung TY. Comparison of clinical outcomes of toric intraocular lens, Precizon vs Tecnis: a single center randomized controlled trial. BMC Ophthalmol. 2018 Nov 9;18(1):292. doi: 10.1186/s12886-018-0955-3.

    PMID: 30413154DERIVED

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Samsung Medical Center

Study Record Dates

First Submitted

March 11, 2017

First Posted

March 21, 2017

Study Start

April 1, 2016

Primary Completion

July 1, 2016

Study Completion

October 1, 2016

Last Updated

March 21, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share