Outcomes of Clareon PanOptix Pro in Patients With Prior Myopic Refractive Surgery
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 Pro IOL.
- Who it may be relevant to
- Registry conditions: Cataract. Basic parameters: from 45 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 →
Official title
Visual and Refractive Outcomes of the Clareon PanOptix Pro IOL in Patients With Prior Myopic Refractive Surgery
Overview
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.
Interventions
- Device Clareon PanOptix Pro IOL
Spherical and toric T3
Primary outcome measures
- Binocular corrected distance visual acuity (logMAR) [Time frame: 3 months postoperative]
Secondary outcome measures (5)
- Binocular distance corrected visual acuity at intermediate (logMAR) [Time frame: 3 months postoperative]
- Binocular distance corrected visual acuity at near (logMAR) [Time frame: 3 months postoperative]
- Binocular unccorrected visual acuity at distance (logMAR) [Time frame: 3 months postoperative]
- Binocular unccorrected visual acuity at intermediate (logMAR) [Time frame: 3 months postoperative]
- Binocular unccorrected visual acuity at near (logMAR) [Time frame: 3 months postoperative]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Juliette Eye Institute Research Center — Albuquerque
Identifiers
NCT: NCT06555289 · RM-24-01