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Comparing Visual Outcomes in Matched Patients Receiving a Low Cylinder Power Toric IOL or a Non-toric IOL

NCT ID: NCT06717607

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-20

Study Completion Date

2024-08-30

Brief Summary

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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.

Detailed Description

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The Clareon(R) T2 IOL and the Clareon (R) non-toric IOL will be randomly implanted in subjects determined to be appropriate for the T2 IOL. Visual acuity, low contrast acuity and contrast sensitivity will be measured 3 months postoperatively.

Conditions

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Cataract and IOL Surgery

Keywords

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Toric IOL

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Clareon T2 IOL implantation

low cylinder toric IOL

Group Type EXPERIMENTAL

low cylinder toric IOL

Intervention Type DEVICE

Clareon T2 toric IOL implantation

Clareon non-toric IOL implantation

Non-toric IOL

Group Type ACTIVE_COMPARATOR

non-toric IOL implantation

Intervention Type DEVICE

Clareon non-toric IOL

Interventions

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low cylinder toric IOL

Clareon T2 toric IOL implantation

Intervention Type DEVICE

non-toric IOL implantation

Clareon non-toric IOL

Intervention Type DEVICE

Other Intervention Names

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Clareon T2 IOL implantation Clareon non-toric IOL implantation

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* pathology that would confound outcomes, previous ocular surgery
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role collaborator

Ifocus Oyeklinikk

NETWORK

Sponsor Role lead

Responsible Party

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Morten Gundersen

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kjell Gunnar Gundersen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ifocus Oyeklinikk

Locations

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Ifocus øyeklinikk

Haugesund, , Norway

Site Status

Countries

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Norway

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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370677

Identifier Type: OTHER

Identifier Source: secondary_id

KGG-2021-01

Identifier Type: -

Identifier Source: org_study_id