Evaluating Clareon PanOptix outcomes in cataract patients with prior myopic surgery

Visual and Refractive Outcomes of the Clareon PanOptix Pro IOL in Patients With Prior Myopic Refractive Surgery

This study is testing how well the Clareon PanOptix lenses work for people with cataracts who have had previous eye surgery to see if they improve vision after surgery.

Quick facts

• Study type: Observational
• Enrollment: 40 (estimated)
• Ages: 45 Years and up
• Sex: All
• Sponsor: Juliette Eye Institute Research Center (other)
• Locations: 1 site (Albuquerque, New Mexico)
• Trial ID: NCT06555289 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 45 and older with age-related cataracts and a history of myopic PRK or LASIK.

Not a fit: Patients with significant ocular comorbidities or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of how Clareon PanOptix IOLs perform in patients with a history of myopic refractive surgery, potentially leading to improved surgical outcomes.

How similar studies have performed: While this approach is observational, similar studies have shown promising outcomes with advanced IOLs in cataract surgery, suggesting potential for success.

Eligibility criteria

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 this trial is running

Albuquerque, New Mexico

• 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

Conditions: Cataract