Evaluating Clareon PanOptix outcomes in cataract patients with prior myopic surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study focuses on the clinical outcomes of patients undergoing bilateral cataract surgery with the implantation of Clareon PanOptix intraocular lenses (IOL). Participants will be assessed before surgery and at one and three months post-surgery, with evaluations including visual acuity measurements and questionnaire assessments. The study aims to gather data on the effectiveness of the PanOptix IOL in patients who have previously undergone myopic refractive surgery. It is a single-center, single-arm study designed to provide insights into postoperative visual outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Juliette Eye Institute Research Center
  Albuquerque, New Mexico, United States Recruiting

Study contacts

• Principal investigator: Robert Melendez, MD, MBA — Juliette Eye Institute Research Center
• Study coordinator: Zoe Baker, OD
• Email: dr.baker@julietteeye.com
• Phone: 505-355-2020

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.