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Clinical Trials/NCT06717607
NCT06717607
Completed
Not Applicable

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

Ifocus Oyeklinikk1 site in 1 country43 target enrollmentAugust 20, 2022
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ConditionsCataract and IOL Surgery

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cataract and IOL Surgery
Sponsor
Ifocus Oyeklinikk
Enrollment
43
Locations
1
Primary Endpoint
Uncorrected distance visual acuity (UDVA)
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
August 20, 2022
End Date
August 30, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Ifocus Oyeklinikk
Responsible Party
Principal Investigator
Principal Investigator

Morten Gundersen

MD

Ifocus Oyeklinikk

Eligibility Criteria

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

Outcomes

Primary Outcomes

Uncorrected distance visual acuity (UDVA)

Time Frame: 3 months

UDVA (logMAR)

Secondary Outcomes

  • 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)
  • Mesopic contrast sensitivity(3 months)
  • Photopic contrast sensitivity(3 months)
  • Low contrast visual acuity(3 months)

Study Sites (1)

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