Ovo Lasik + Lens
Saint Louis Park, Minnesota, 55416, United States
Location status: Recruiting
Location contact
Ashley Prepeluh
CONTACT
Mark C Lobanoff, MD
PRINCIPAL_INVESTIGATOR
Martha F Whiting, MD
PRINCIPAL_INVESTIGATOR
Recruiting
NCT Number: NCT07648355
Visual and Patient Reported Outcomes With Clareon TruPlus
This is a prospective, single-site, two-surgeon, single-arm, observational study evaluating the Clareon TruPlus IOL. Subjects will be assessed up to 3 months post-operatively. Clinical evaluations will include refractive outcomes, visual acuity, and administration of the IOLSAT Questionnaire.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Willing and able to understand and sign informed consent.
- Adult patients (>40 years old) undergoing age-related cataract surgery with expected best-corrected visual outcomes of 20/25 or better in both eyes pre-operatively as determined by surgeon and with regular corneal astigmatism correctable to less than 0.75 diopters post-operatively with no more than a T6 toric power IOL.
- Normal ocular findings aside from cataract and mild dry eye.
Exclusion criteria
- Subjects targeted for monovision.
- Moderate-severe corneal pathology, irregular astigmatism, preexisting macular disease and other retinal degenerative diseases, diabetic retinopathy that is expected to cause future vision loss, glaucoma, severe dry eye disease, nystagmus, strabismus, amblyopia, zonular laxity or dehiscence, pseudoexfoliation.
- Previous history of any ocular surgery including LASIK (excluding minor lid procedures).
- Patients with irregular astigmatism/topography, corneal dystrophies, and pupil abnormalities.
- Participation in another clinical study that could interfere with the results.
- Any active ocular infection or inflammation.
Treatment and study plan
Clareon TruPlus
DeviceClareon TruPlus
Primary outcomes
-
Binocular photopic DCIVA
Time frame: 3 months postoperatively
Measured using a standardized ETDRS chart at 66cm.
Secondary outcomes
-
Binocular photopic CDVA
Time frame: 3 months postoperatively
Measured using a standardized ETDRS chart at 4m.
Other outcomes
-
Binocular photopic DCNVA
Time frame: 3 months postoperatively
Measured using a standardized ETDRS chart at 40cm.
-
Binocular uncorrected distance visual acuity UDVA (4m)
Time frame: 3 months postoperatively
Measured using a standardized ETDRS charts
-
Binocular photopic uncorrected intermediate visual acuity UIVA (66cm)
Time frame: 3 months postoperatively
Measured using a standardized ETDRS charts
-
Binocular photopic uncorrected near visual acuity UNVA (40cm)
Time frame: 3 months postoperatively
Measured using a standardized ETDRS charts
-
Monocular photopic uncorrected distance visual acuity UDVA (4m)
Time frame: 3 months postoperatively
Measured using a standardized ETDRS charts
-
Monocular photopic uncorrected intermediate visual acuity UIVA (66cm)
Time frame: 3 months postoperatively
Measured using a standardized ETDRS charts
-
Monocular photopic uncorrected near visual acuity UNVA (40cm)
Time frame: 3 months postoperatively
Measured using a standardized ETDRS charts
-
Monocular photopic corrected distance visual acuity CDVA (4m)
Time frame: 3 months postoperatively
Measured using a standardized ETDRS charts
-
Monocular photopic distance corrected intermediate visual acuity DCIVA (66cm)
Time frame: 3 months postoperatively
Measured using a standardized ETDRS charts
-
Monocular photopic distance corrected near visual acuity DCNVA (40cm)
Time frame: 3 months postoperatively
Measured using a standardized ETDRS charts
-
Monocular defocus curve
Time frame: 3 months postoperatively
Measured using a standardized ETDRS chart
-
Refractive outcomes
Time frame: 3 months postoperatively
sphere and cylinder will be combined to determine MRSE (sphere + cylinder/2) = MRSE
-
Satisfaction questionniar
Time frame: 3 months postoperatively
The Intraocular Lens Satisfaction questionnaire (IOLSAT). Lower scores indicate higher satisfaction.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
OVO LASIK + Lens
Other
Collaborators
- Sengi
Registry information
Official study title
Visual and Patient Reported Outcomes of Clareon TruPlus IOL in Cataract Surgery Patients
Important dates
- Study start
- 2026
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Jun 15, 2026
- 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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