Cataract and IOL Surgery
Conditions
Keywords
Toric IOL
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.
Interventions
DEVICElow cylinder toric IOL
Clareon T2 toric IOL implantation
Clareon non-toric IOL
Sponsors
Ifocus Oyeklinikk
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| UDVA | 3 months | Uncorrected distance visual acuty in logMAR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Manifest Refractive Cylinder | 3 months | Manifest refractive cylinder, in diopters |
| Percentage of Eyes With <= 0.25 D of Refractive Cylinder | 3 months | the percentage of eyes with \<= 0.25 D of postoperative refractive cylinder |
| Percentage of Eyes With <= 0.50 D of Refractive Cylinder | 3 months | The percentage of eyes with \<= 0.50 D of refractive cylinder |
| Corrected Distance Visual Acuity | 3 months | Corrected distance visual acuity (CDVA), logMAR |
| Mesopic Contrast Sensitivity | 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) |
| Photopic Contrast Sensitivity | 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) |
| Low Contrast Visual Acuity | 3 months | Low contrast visual acuity (VA), logMAR, 10% contrast, using the Clinical Trial Suite (CTS) from M\&S Technologies (Niles, IL, 129 USA) |
| Mean Refraction, Spherical Equivalent (MRSE) | 3 months | Mean refraction, spherical equivalent (MRSE), in diopters |
Countries
Norway
Contacts
PRINCIPAL_INVESTIGATORKjell Gunnar Gundersen, MD, PhD
Ifocus Oyeklinikk
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 74 Years STANDARD_DEVIATION 6 |
| Race and Ethnicity Not Collected | 0 Participants |
| Region of Enrollment Norway | 18 Participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 18 |
| other Total, other adverse events | 0 / 25 | 0 / 18 |
| serious Total, serious adverse events | 0 / 25 | 0 / 18 |
Outcome results
None listed