Clinical trial NCT06922084: A Prospective, Randomized, Subject and Vision-assessor Masked, Multicenter Study Comparing Bilateral Clareon PanOptix, Bilateral Clareon PanOptix Pro, and Mixed Clareon PanOptix Pro/Vivity Intraocular Lens Implantation in Cataract Subjects
Official title: A Prospective, Randomized, Subject and Vision-assessor Masked, Multicenter Study Comparing Bilateral Clareon PanOptix, Bilateral Clareon PanOptix Pro, and Mixed Clareon PanOptix Pro/Vivity Intraocular Lens Implantation in Cataract Subjects
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Cataract
Lead sponsor: Berkeley Eye Center
Sponsor class: OTHER
Collaborators: name: Sengi
First posted: 2025-04-10
Enrollment: 320
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective, randomized, multicenter, multi-arm, subject and vision-assessor-masked, two stage study with Stage 1 as a three-arm initial enrollment period, followed by Stage 2 as a head-to-head study refined based on the Stage 1 data.


Eligibility criteria: Inclusion Criteria:

* Adult cataract patients aged 40 years and older scheduled for age related cataract surgery in both eyes.
* Ability to understand and sign an ethics committee-approved informed consent form.
* Willingness and ability to attend all scheduled study visits as required by the protocol.
* Postoperative potential visual acuity of 20/25 or better in each eye, as determined by the investigator.
* Preoperative corneal astigmatism that can be corrected with a T3 or T4 toric IOL, or with a spherical IOL and LRIs or AKs resulting in a predicted postoperative astigmatism of less than 0.5 diopters (D).
* Ability to understand and complete questionnaires.

Exclusion Criteria:

* Women who are pregnant, planning to become pregnant during the study, or breastfeeding.
* Ocular conditions that could confound study results, including moderate to severe corneal pathology, irregular astigmatism, moderate to severe dry eye, preexisting retinal diseases such as macular degeneration or diabetic retinopathy.
* Any form of confirmed glaucomatous damage (ie, mild, moderate, or severe glaucoma).
* Participation in another clinical study that could interfere with the results.
* Systemic conditions that may affect healing or visual outcomes (e.g., uncontrolled diabetes mellitus, certain autoimmune disorders).
* Subjects with nystagmus, strabismus, zonular laxity or dehiscence, and pseudoexfoliation.
* Prior ocular surgery (except for uncomplicated cataract surgery in the fellow eye).
* Participants desiring monovision.
* Any active ocular infection or inflammation (except for routine post-operative inflammation in the fellow eye)
* Psychiatric or cognitive disorders that may impair the ability to comply with study procedures or provide accurate self-assessments.
* RMS total higher-order aberrations (HOAs) \>0.70 µm or coma \>0.40 µm as measured by tomography or topography with a 4 mm pupil setting.

Primary outcomes:
measure: Binocular photopic CDVA (corrected distance visual acuity)
timeFrame: 3 months postoperatively
Secondary outcomes:
measure: Binocular photopic DCIVA (distance corrected intermediate visual acuity) and DCNVA (distance corrected near visual acuity)
timeFrame: 3 months postoperatively
measure: Binocular photopic uncorrected visual acuity at distance (UDVA), intermediate (UIVA), and near (UNVA)
timeFrame: 3 months postoperatively
measure: Binocular photopic small letter contrast sensitivity at 66 cm and 100 cm with refractive distance correction (20/32 line)
timeFrame: 3 months postoperatively
measure: Binocular mesopic high contrast distance corrected visual acuity at distance (CDVA), intermediate (DCIVA), and near (DCNVA).
timeFrame: 3 months postoperatively
measure: Binocular photopic distance corrected defocus curve
timeFrame: 3 months postoperatively
measure: Monocular photopic distance corrected defocus curves
timeFrame: 3 months postoperatively
measure: Binocular mesopic distance corrected contrast sensitivity with and without glare (1.5, 3, 6 & 12 cpd)
timeFrame: 3 months postoperatively
measure: Refractive outcomes
timeFrame: 3 months postoperatively
measure: Pupil size
timeFrame: 3 months postoperatively
measure: Patient-reported outcomes using a questionnaire about visual disturbances (QUVID)
timeFrame: 3 months postoperatively
measure: Patient-reported outcomes using a questionnaire about IOL satisfaction (IOLSAT)
timeFrame: 3 months postoperatively
Other outcomes:
Locations:
city: Plymouth Meeting
country: United States
facility: Shafer Vision Institute
state: Pennsylvania
city: Houston
country: United States
facility: Berkeley Eye Center
state: Texas
Study officials:
affiliation: Berkeley Eye Center
name: Morgan Micheletti, MD
role: PRINCIPAL_INVESTIGATOR
References: