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

November 30, 2024 updated by: Morten Gundersen, Ifocus Oyeklinikk
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Haugesund, Norway, 5521
        • Ifocus øyeklinikk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Clareon T2 IOL implantation
low cylinder toric IOL
Device: low cylinder toric IOL
Clareon T2 toric IOL implantation
Other Names:
  • Clareon T2 IOL implantation
Active Comparator: Clareon non-toric IOL implantation
Non-toric IOL
Device: non-toric IOL implantation
Clareon non-toric IOL
Other Names:
  • Clareon non-toric IOL implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uncorrected distance visual acuity (UDVA)
Time Frame: 3 months
UDVA (logMAR)
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean refraction, spherical equivalent (MRSE)
Time Frame: 3 months
MRSE, diopters
3 months
Manifest refractive cylinder
Time Frame: 3 months
Manifest cylinder, diopters
3 months
Percentage of eyes with <= 0.25 D of refractive cylinder
Time Frame: 3 months
As above
3 months
Percentage of eyes with <= 0.50 D of refractive cylinder
Time Frame: 3 months
As above
3 months
Corrected distance visual acuity
Time Frame: 3 months
CDVA, logMAR
3 months
Mesopic contrast sensitivity
Time Frame: 3 months
Contrast sensitivity curve
3 months
Photopic contrast sensitivity
Time Frame: 3 months
Contrast sensitivity curve
3 months
Low contrast visual acuity
Time Frame: 3 months
Visual acuity (VA), logMAR
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ifocus Oyeklinikk

Collaborators

Alcon Research

Investigators

  • Principal Investigator: Kjell Gunnar Gundersen, MD, PhD, Ifocus Oyeklinikk

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 20, 2022

Primary Completion (Actual)

August 30, 2024

Study Completion (Actual)

August 30, 2024

Study Registration Dates

First Submitted

November 30, 2024

First Submitted That Met QC Criteria

November 30, 2024

First Posted (Estimated)

December 5, 2024

Study Record Updates

Last Update Posted (Estimated)

December 5, 2024

Last Update Submitted That Met QC Criteria

November 30, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KGG-2021-01
  • 370677 (Other Identifier: REK Norway Ethics Committee)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cataract and IOL Surgery

Clinical Trials on low cylinder toric IOL

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ukraine

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe