Visual and Patient Reported Outcomes With Clareon TruPlus
1 other identifier
observational
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 2, 2026
CompletedFirst Submitted
Initial submission to the registry
June 4, 2026
CompletedFirst Posted
Study publicly available on registry
June 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 11, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 11, 2027
June 15, 2026
June 1, 2026
1.1 years
June 4, 2026
June 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Binocular photopic DCIVA
Measured using a standardized ETDRS chart at 66cm.
3 months postoperatively
Secondary Outcomes (1)
Binocular photopic CDVA
3 months postoperatively
Other Outcomes (13)
Binocular photopic DCNVA
3 months postoperatively
Binocular uncorrected distance visual acuity UDVA (4m)
3 months postoperatively
Binocular photopic uncorrected intermediate visual acuity UIVA (66cm)
3 months postoperatively
- +10 more other outcomes
Study Arms (1)
Clareon TruPlus
Interventions
Eligibility Criteria
Adults over 40 years undergoing age-related cataract surgery with expected visual outcomes of 20/25 or better.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- OVO LASIK + Lenslead
- Sengicollaborator
Study Sites (1)
Ovo Lasik + Lens
Saint Louis Park, Minnesota, 55416, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martha Whiting, MD
OVO Lasik and Lens LLC
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2026
First Posted
June 15, 2026
Study Start
June 2, 2026
Primary Completion (Estimated)
July 11, 2027
Study Completion (Estimated)
July 11, 2027
Last Updated
June 15, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share