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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

ConditionCataract
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age40+
SponsorBerkeley Eye Center

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Clareon PanOptix

    Device

    Bilateral Clareon PanOptix IOL implantation

  • Clareon PanOptix PRO

    Drug

    Bilateral Clareon PanOptix PRO IOL implantation

  • Mix-and-Match PanOptix/Vivity

    Drug

    Clareon PanOptix Pro in the non-dominant eye and Clareon Vivity in the dominant eye

Treatment groups

320 Participants
are divided into 3 treatment groups
Group A: Bilateral Clareon PanOptix IOL implantationActive comparator 1 intervention
Group B: Bilateral Clareon PanOptix Pro IOL implantationExperimental treatment 1 intervention
Group C: Clareon PanOptix Pro in the non-dominant eye and Clareon Vivity in the dominant eyeExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Binocular photopic CDVA (corrected distance visual acuity)

Time frame
3 months postoperatively

Secondary outcomes

1

Binocular photopic DCIVA (distance corrected intermediate visual acuity) and DCNVA (distance corrected near visual acuity)

Time frame
3 months postoperatively
2

Binocular photopic uncorrected visual acuity at distance (UDVA), intermediate (UIVA), and near (UNVA)

Time frame
3 months postoperatively
3

Binocular photopic small letter contrast sensitivity at 66 cm and 100 cm with refractive distance correction (20/32 line)

Time frame
3 months postoperatively
4

Binocular mesopic high contrast distance corrected visual acuity at distance (CDVA), intermediate (DCIVA), and near (DCNVA).

Time frame
3 months postoperatively

Other outcomes

Sponsors and contacts

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

Berkeley Eye Center

Lead sponsor

Sengi

Collaborator

Source ClinicalTrials.gov
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