Outcomes of Clareon PanOptix in Patients With Prior Myopic Refractive Surgery

Juliette Eye Institute Research Center

Status: Enrolling

Conditions: Cataract

Treatments: Device: Clareon PanOptix IOL

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06555289

RM-24-01

Details and patient eligibility

About

This study is a Single center, single arm, prospective, observational study of clinical outcomes following bilateral cataract surgery and Clareon PanOptix 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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 spherical IOL.
• Patients who have regular corneal astigmatism and are candidates for PanOptix 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.