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OpenTrials
Completed

NCT Number: NCT06717607

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

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ifocus øyeklinikk

Haugesund, 5521, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

low cylinder toric IOL

Device

Clareon T2 toric IOL implantation

Other names: Clareon T2 IOL implantation

Non-toric IOL implantation

Device

Clareon non-toric IOL

Other names: Clareon non-toric IOL implantation

Primary outcomes

  1. UDVA

    Time frame: 3 months

    Uncorrected distance visual acuty in logMAR

Secondary outcomes

  1. Manifest Refractive Cylinder

    Time frame: 3 months

    Manifest refractive cylinder, in diopters

  2. Percentage of Eyes With <= 0.25 D of Refractive Cylinder

    Time frame: 3 months

    the percentage of eyes with <= 0.25 D of postoperative refractive cylinder

  3. Percentage of Eyes With <= 0.50 D of Refractive Cylinder

    Time frame: 3 months

    The percentage of eyes with <= 0.50 D of refractive cylinder

  4. Corrected Distance Visual Acuity

    Time frame: 3 months

    Corrected distance visual acuity (CDVA), logMAR

  5. Mesopic Contrast Sensitivity

    Time frame: 3 months

    Mesopic log contrast sensitivity by spatial frequency - cycles per degree (CPD), using the Clinical Trial Suite (CTS) from M&S Technologies (Niles, IL, 129 USA)

  6. Photopic Contrast Sensitivity

    Time frame: 3 months

    Photopic log contrast sensitivity by spatial frequency - cycles per degree (CPD), using the Clinical Trial Suite (CTS) from M&S Technologies (Niles, IL, 129 USA)

  7. Low Contrast Visual Acuity

    Time frame: 3 months

    Low contrast visual acuity (VA), logMAR, 10% contrast, using the Clinical Trial Suite (CTS) from M&S Technologies (Niles, IL, 129 USA)

  8. Mean Refraction, Spherical Equivalent (MRSE)

    Time frame: 3 months

    Mean refraction, spherical equivalent (MRSE), in diopters

Sponsors and collaborators

Lead sponsor

Ifocus Oyeklinikk

Network

Collaborators

  • Alcon Research

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 5, 2024
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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