Cataract and IOL SurgeryNCT06717607
Comparing Visual Outcomes in Matched Patients Receiving a Low Cylinder Power Toric IOL or a Non-toric IOL
A study testing low cylinder toric IOL and non-toric IOL implantation in people with Cataract and IOL Surgery, run by Ifocus Oyeklinikk at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract and IOL Surgery
- What is being tested?
- low cylinder toric IOL and non-toric IOL implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteNorway
- Study dates
- 20 Aug 2022to 30 Aug 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- candidate for cataract surgery, suitable for implantation with a low cylinder toric IOL
Who cannot join
- pathology that would confound outcomes, previous ocular surgery
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cataract and IOL Surgery
- Being tested
- low cylinder toric IOL, non-toric IOL implantation
- Keywords
- Toric IOL
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low cylinder toric IOLDevice
Also called Clareon T2 IOL implantation
Clareon T2 toric IOL implantation
non-toric IOL implantationDevice
Also called Clareon non-toric IOL implantation
Clareon non-toric IOL
| Study group | Role | What they receive |
|---|---|---|
| Clareon T2 IOL implantation | Experimental | low cylinder toric IOL Receives: Device: low cylinder toric IOL |
| Clareon non-toric IOL implantation | Active comparator | Non-toric IOL Receives: Device: non-toric IOL implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
UDVA
Uncorrected distance visual acuty in logMAR
Measured: 3 months
Secondary outcomes (8)
Manifest Refractive Cylinder
Manifest refractive cylinder, in diopters
Measured: 3 months
Percentage of Eyes With <= 0.25 D of Refractive Cylinder
the percentage of eyes with <= 0.25 D of postoperative refractive cylinder
Measured: 3 months
Percentage of Eyes With <= 0.50 D of Refractive Cylinder
The percentage of eyes with <= 0.50 D of refractive cylinder
Measured: 3 months
Corrected Distance Visual Acuity
Corrected distance visual acuity (CDVA), logMAR
Measured: 3 months
Mesopic Contrast Sensitivity
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)
Measured: 3 months
Photopic Contrast Sensitivity
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)
Measured: 3 months
Low Contrast Visual Acuity
Low contrast visual acuity (VA), logMAR, 10% contrast, using the Clinical Trial Suite (CTS) from M\&S Technologies (Niles, IL, 129 USA)
Measured: 3 months
Mean Refraction, Spherical Equivalent (MRSE)
Mean refraction, spherical equivalent (MRSE), in diopters
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start20 Aug 2022
- Primary completion30 Aug 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cataract and IOL SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ifocus Oyeklinikk
- Sponsor type
- Research network
- Collaborators
- Alcon Research
- Responsible party
- Principal investigator, Morten Gundersen, Ifocus Oyeklinikk
- Investigators
- Kjell Gunnar Gundersen, MD, PhD, Principal investigator, Ifocus Oyeklinikk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06717607
- Sponsor's protocol ID
- KGG-2021-01
- Other IDs
- 370677
- Status last verified
- May 2026
- First submitted
- 30 Nov 2024
- Last updated
- 15 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Gundersen KG, Potvin R, Ostenstad SA. Comparing visual outcomes in matched patients receiving a low cylinder power toric IOL or a non-toric IOL. Front Ophthalmol (Lausanne). 2026 Jul 23;6:1755069. doi: 10.3389/fopht.2026.1755069. eCollection 2026.
PubMed 42564736
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Visual Outcomes in Matched Patients Receiving a Low Cylinder Power Toric IOL or a Non-toric IOL
- ClinicalTrials.gov ID
- NCT06717607
- Acronym / sponsor ID
- KGG-2021-01
- Conditions
- Cataract and IOL Surgery
- Keywords
- Toric IOL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Ifocus OyeklinikkResearch network
- Collaborators
- Alcon Research
- Study start
- 20 Aug 2022 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 5 Dec 2024 (actual)
- Results
- Posted 15 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clareon T2 IOL implantation | Experimental | Device: low cylinder toric IOLlow cylinder toric IOL |
| Clareon non-toric IOL implantation | Active comparator | Device: non-toric IOL implantationNon-toric IOL |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- candidate for cataract surgery, suitable for implantation with a low cylinder toric IOL
Key exclusion criteria (1 listed)
- pathology that would confound outcomes, previous ocular surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low cylinder toric IOLAlso: Clareon T2 IOL implantationClareon T2 toric IOL implantation | Device | Clareon T2 IOL implantation |
| non-toric IOL implantationAlso: Clareon non-toric IOL implantationClareon non-toric IOL | Device | Clareon non-toric IOL implantation |
Primary outcome
UDVA
Time frame: 3 months
Uncorrected distance visual acuty in logMAR
8 secondary outcomes
Manifest Refractive Cylinder
Time frame: 3 months
Percentage of Eyes With <= 0.25 D of Refractive Cylinder
Time frame: 3 months
Percentage of Eyes With <= 0.50 D of Refractive Cylinder
Time frame: 3 months
Corrected Distance Visual Acuity
Time frame: 3 months
Mesopic Contrast Sensitivity
Time frame: 3 months
Photopic Contrast Sensitivity
Time frame: 3 months
Low Contrast Visual Acuity
Time frame: 3 months
Mean Refraction, Spherical Equivalent (MRSE)
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42564736Gundersen KG, Potvin R, Ostenstad SA. Comparing visual outcomes in matched patients receiving a low cylinder power toric IOL or a non-toric IOL. Front Ophthalmol (Lausanne). 2026 Jul 23;6:1755069. doi: 10.3389/fopht.2026.1755069. eCollection 2026.
Related trials for Cataract and IOL Surgery
Not yet recruitingObservational study
Postoperative Outcome Verification of Discrepant Toric IOL Calculator Recommendations After Cataract Surgery
Cataract
Not yet recruitingObservational study
Post-Market Clinical Follow-Up Study on the Rotational Stability of an Intraocular Lens After Cataract Surgery
IOL, Cataract
RecruitingObservational study
Postoperative Outcomes of a Toric AddOn Intraocular Lens After Keratoplasty and Cataract Surgery
Cataract and IOL Surgery, Keratoplasty
Active, not recruitingObservational study
Diabetic Nephropathy, Glycemic Control and Pseudophakic Macular Edema After Cataract Surgery
Pseudophakic Macular Edema, Diabetic Nephropathies
Not yet recruiting
Partial Range Of Field IOLs in DMEK-Enabled Procedures
Cataract, Fuchs Endothelial Corneal Dystrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kjell Gunnar Gundersen, MD, PhD principal investigator
Ifocus Oyeklinikk
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low cylinder toric IOL and non-toric IOL implantation in people with Cataract and IOL Surgery, run by Ifocus Oyeklinikk at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UDVA (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06717607, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.