Outcomes of Clareon PanOptix Pro in Patients With Prior Myopic Refractive Surgery
Recruiting now
Conditions studied: Cataract
In brief
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.
Key facts
- Study ID
- NCT06555289
- Run by
- Juliette Eye Institute Research Center
- People needed
- 40
- Starts
- 2024-10-23
- Expected to finish
- 2026-09-01
- Last updated by the study team
- 2025-12-12
Who can join
Age: 45 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 is running
- Juliette Eye Institute Research Center — Albuquerque, New Mexico, United States (enrolling)
Full record on ClinicalTrials.gov
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