Menu
Recruiting 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

Phase IV Interventional Cataract

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Clareon PanOptix, Clareon PanOptix PRO, Mix-and-Match PanOptix/Vivity.
Who it may be relevant to
Registry conditions: Cataract. Basic parameters: from 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device Clareon PanOptix
    Bilateral Clareon PanOptix IOL implantation
  • Drug Clareon PanOptix PRO
    Bilateral Clareon PanOptix PRO IOL implantation
  • Drug Mix-and-Match PanOptix/Vivity
    Clareon PanOptix Pro in the non-dominant eye and Clareon Vivity in the dominant eye

Primary outcome measures

  • Binocular photopic CDVA (corrected distance visual acuity) [Time frame: 3 months postoperatively]
Secondary outcome measures (11)
  • Binocular photopic DCIVA (distance corrected intermediate visual acuity) and DCNVA (distance corrected near visual acuity) [Time frame: 3 months postoperatively]
  • Binocular photopic uncorrected visual acuity at distance (UDVA), intermediate (UIVA), and near (UNVA) [Time frame: 3 months postoperatively]
  • Binocular photopic small letter contrast sensitivity at 66 cm and 100 cm with refractive distance correction (20/32 line) [Time frame: 3 months postoperatively]
  • Binocular mesopic high contrast distance corrected visual acuity at distance (CDVA), intermediate (DCIVA), and near (DCNVA). [Time frame: 3 months postoperatively]
  • Binocular photopic distance corrected defocus curve [Time frame: 3 months postoperatively]
  • Monocular photopic distance corrected defocus curves [Time frame: 3 months postoperatively]
  • Binocular mesopic distance corrected contrast sensitivity with and without glare (1.5, 3, 6 & 12 cpd) [Time frame: 3 months postoperatively]
  • Refractive outcomes [Time frame: 3 months postoperatively]
  • Pupil size [Time frame: 3 months postoperatively]
  • Patient-reported outcomes using a questionnaire about visual disturbances (QUVID) [Time frame: 3 months postoperatively]
  • Patient-reported outcomes using a questionnaire about IOL satisfaction (IOLSAT) [Time frame: 3 months postoperatively]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 2 centers
  • Shafer Vision Institute — Plymouth Meeting
  • Berkeley Eye Center — Houston

Identifiers

NCT: NCT06922084 · 95474481

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗