Visual and Patient Reported Outcomes With Clareon TruPlus

ConditionCataract

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorOVO LASIK + Lens

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Adults over 40 years undergoing age-related cataract surgery with expected visual outcomes of 20/25 or better.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Clareon TruPlus
Device
Clareon TruPlus

Treatment groups

40 Participants

are divided into 1 treatment group

Group A: Clareon TruPlus1 intervention

Trial outcomes

Primary outcomes

Binocular photopic DCIVA

Measured using a standardized ETDRS chart at 66cm.

Time frame

3 months postoperatively

Secondary outcomes

Binocular photopic CDVA

Measured using a standardized ETDRS chart at 4m.

Time frame

3 months postoperatively

Other outcomes

Binocular photopic DCNVA

Measured using a standardized ETDRS chart at 40cm.

Time frame

3 months postoperatively

Binocular uncorrected distance visual acuity UDVA (4m)

Measured using a standardized ETDRS charts

Time frame

3 months postoperatively

Binocular photopic uncorrected intermediate visual acuity UIVA (66cm)

Measured using a standardized ETDRS charts

Time frame

3 months postoperatively

Binocular photopic uncorrected near visual acuity UNVA (40cm)

Measured using a standardized ETDRS charts

Time frame

3 months postoperatively

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

OVO LASIK + Lens

Lead sponsor

Sengi

Collaborator

Source ClinicalTrials.gov

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