Outcomes of Clareon PanOptix Pro in Patients With Prior Myopic Refractive Surgery (NCT06555289) | Clinical Trial Compass
RecruitingNot Applicable
Outcomes of Clareon PanOptix Pro in Patients With Prior Myopic Refractive Surgery
United States40 participantsStarted 2024-10-23
Plain-language summary
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.
Who can participate
Age range
45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.