Recruiting

Clareon PanOptix

Sponsor:

Juliette Eye Institute Research Center

Code:

NCT06555289

Conditions

Cataract

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

Interventions

Clareon PanOptix Pro IOL

Study Details

Brief summary:

This study is a Single center, single arm, prospective, observational study of clinical outcomes following bilateral cataract surgery and Clareon PanOptix Pro implantation. Subjects will be assessed preoperatively, and at 1 and 3 months postoperatively. Clinical evaluations will include administration of the QUVID and IOLSAT questionnaires, manifest refraction, topography, as well as measurement of visual acuities at distance, intermediate, and near.

Conditions

Cataract

Study ID

NCT06555289

Start date

Oct 23, 2024

Status verified date

Dec, 2025

Completion date

Sep 1, 2026

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adults (45 years or older) who have confirmed age-related cataracts and are eligible for bilateral cataract surgery.
  • Prior binocular myopic photorefractive keratectomy (PRK) or myopic LASIK.
  • Patients who have regular corneal astigmatism less than or equal to 0.6 D and are candidates for the PanOptix Pro spherical IOL.
  • Patients who have regular corneal astigmatism and are candidates for PanOptix Pro toric IOL T3
  • Postoperative visual potential of monocular 20/25 or better, in the surgeon's judgement.

Exclusion Criteria:

  • Any ocular comorbidity that might hamper postoperative visual acuity:

  • Corneal abnormality including corneal dystrophy, irregularity, and degeneration.
  • Moderate or severe dry eyes that can't be relieved after treatment.
  • History of or current anterior and posterior inflammation of any etiology.
  • Retinal pathology such as AMD, diabetic retinopathy, vein occlusion, etc.
  • Glaucoma of any kind.
  • Pregnancy or lactation.
  • Any ocular surgery other than corneal myopic refractive surgery (LASIK and PRK).
  • Patients with physical or intellectual disability (e.g. Down's Syndrome, Parkinson's Disease, unable to fixate)
  • Apple Kappa/chord mu ≥ 0.6.
  • Higher order corneal aberrations at pupil diameter of 4mm: > 0.6 total RMS, > 0.3 coma, > 0.3 trefoil (to exclude irregular corneas)
  • Any patient requiring a limbal relaxing incision.

The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Interventions

Clareon PanOptix Pro IOL

Spherical and toric T3

Primary outcome measure

  • Binocular corrected distance visual acuity (logMAR) [ Time Frame: 3 months postoperative ]

Central Contacts and Locations

Central contacts

Zoe Baker, OD

505-355-2020dr.baker@julietteeye.com

Locations

Juliette Eye Institute Research Center

Recruiting

Albuquerque, New Mexico, United States, 87113

Contacts

Zoe Baker, OD

505-355-2020dr.baker@julietteeye.com

Principal Investigator:

Robert Melendez, MD, MBA

More Information

Sponsor

Juliette Eye Institute Research Center

Last update posted

Dec 12, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Juliette Eye Institute Research Center on 2025-12-12.