Post-refractive IOL Outcomes With Clareon TruPlus
ConditionCataract
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLaser Defined Vision
About this trial
This is a prospective, single-arm, single-center, single-surgeon study evaluating the Clareon TruPlus IOL in post-refractive cataract patients. Subjects will be assessed up to 3 months post-operatively. Clinical evaluations will include refractive outcomes, visual acuity, and administration of the PRISQ Questionnaire.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Willing and able to understand and sign informed consent.
Adult patients (>45 years old) undergoing age-related cataract surgery that previously had myopic corneal refractive surgery.
Dominant eye targeted for emmetropia, non-dominant eye may be targeted for ≤-0.75D (mini-monovision).
Best monocular corrected distance visual acuity expected to be 0.1 logMAR (Snellen 20/25) or better in both eyes pre-operatively as determined by surgeon.
Disqualifiers
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, zonular laxity or dehiscence, pseudoexfoliation.
Previous history of any ocular surgery, except for myopic LASIK or PRK.
Previous hyperopic refractive surgery.
Corneal HOA ≥1.0 µm (RMS) with OPD at 4mm scan.
Trial population
35 adults over 45 years old undergoing cataract surgery post-myopic corneal refractive surgery.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Clareon TruPlus
DeviceClareon TruPlus
Treatment groups
35 Participants
are divided into 1 treatment groupGroup A: Clareon TruPlus1 intervention
Trial outcomes
Primary outcomes
1
Binocular photopic BCDVA (4m)
Measured using standard ETDRS charts and recorded in logMAR
Time frame
3 months postoperativelySecondary outcomes
1
Binocular photopic DCIVA (66cm)
Measured using standard ETDRS charts and recorded in logMAR
Time frame
3 months postoperatively2
Binocular photopic UDVA (4m), UIVA (66cm)
Measured using standard ETDRS charts and recorded in logMAR
Time frame
3 months postoperatively3
Monocular photopic BCDVA (4m), DCIVA (66cm) in dominant and non-dominant eye
Measured using standard ETDRS charts and recorded in logMAR
Time frame
3 months postoperatively4
Binocular distance corrected defocus curve (+1.00 to -2.00 in 0.50D, +0.50 to -0.50 in 0.25D)
Measured using standard ETDRS charts and recorded in logMAR
Time frame
3 months postoperativelyOther outcomes
1
Binocular mesopic BCDVA (4m), DCIVA (66cm)
Measured using standard ETDRS charts and recorded in logMAR
Time frame
3 months postoperatively2
Binocular photopic low contrast (25%) BCDVA
Measured using standard ETDRS charts and recorded in logMAR
Time frame
3 months postoperatively3
Rate of spectacle independence on the PRSIQ questionnaire
Participants are asked to indicate spectacle usage on a scale of "All of the time" to "None of the time" for distance, intermediate, and near vision.
Time frame
3 months postoperativelySponsors and contacts
Click on the lead sponsor to view all of their trials.
Laser Defined Vision
Lead sponsor
Sengi
Collaborator
Source ClinicalTrials.gov