NCT06717607

Brief Summary

The purpose of the study is to determine if visual function is improved with implantation of a low-cylinder toric intraocular lens, relative to a non-toric intraocular lens.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Typical duration 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

Study Start

First participant enrolled

August 20, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 5, 2024

Completed
Last Updated

December 5, 2024

Status Verified

November 1, 2024

Enrollment Period

2 years

First QC Date

November 30, 2024

Last Update Submit

November 30, 2024

Conditions

Cataract and IOL Surgery

Keywords

Toric IOL

Outcome Measures

Primary Outcomes (1)

  • Uncorrected distance visual acuity (UDVA)

    UDVA (logMAR)

    3 months

Secondary Outcomes (8)

  • Mean refraction, spherical equivalent (MRSE)

    3 months

  • Manifest refractive cylinder

    3 months

  • Percentage of eyes with <= 0.25 D of refractive cylinder

    3 months

  • Percentage of eyes with <= 0.50 D of refractive cylinder

    3 months

  • Corrected distance visual acuity

    3 months

  • +3 more secondary outcomes

Study Arms (2)

Clareon T2 IOL implantation

EXPERIMENTAL

low cylinder toric IOL

Device: low cylinder toric IOL

Clareon non-toric IOL implantation

ACTIVE COMPARATOR

Non-toric IOL

Device: non-toric IOL implantation

Interventions

low cylinder toric IOLDEVICE

Clareon T2 toric IOL implantation

Also known as: Clareon T2 IOL implantation
Clareon T2 IOL implantation
non-toric IOL implantationDEVICE

Clareon non-toric IOL

Also known as: Clareon non-toric IOL implantation
Clareon non-toric IOL implantation

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • candidate for cataract surgery, suitable for implantation with a low cylinder toric IOL

You may not qualify if:

  • pathology that would confound outcomes, previous ocular surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ifocus øyeklinikk

Haugesund, 5521, Norway

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Kjell Gunnar Gundersen, MD, PhD

    Ifocus Oyeklinikk

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 30, 2024

First Posted

December 5, 2024

Study Start

August 20, 2022

Primary Completion

August 30, 2024

Study Completion

August 30, 2024

Last Updated

December 5, 2024

Record last verified: 2024-11

Locations

NO(1)