PMCF Retrospective Study Outcomes of a Premium Monofocal IOL (NCT04874376) | Clinical Trial Compass
CompletedNot Applicable
PMCF Retrospective Study Outcomes of a Premium Monofocal IOL
Spain109 participantsStarted 2021-05-24
Plain-language summary
Multicentric, retro- / prospective, open-label, observational PMCF study to investigate visual performance, contrast sensitivity and patient satisfaction after mono- or bilateral implantation of Isopure 1.2.3. intraocular lenses following cataract surgery.
The study treatment itself is not part of this observational clinical investigation. Only patients that already have been implanted with the device under investigation qualify for this retro- prospective observational clinical study.
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:
* • Male or female adults ages 45 years or older on the day of treatment that were mono- or bilaterally implanted with Isopure 1.2.3. intraocular lens minimum 120 days before the study visit;
* Maximum time between first and second eye treatment: 45 days (this accounts for bilateral implantations only);
* Capability to understand and sign an IRB approved informed consent form and privacy authorization;
* Clear intraocular media;
* Minimum set of retrospective preoperative and intraoperative data available as outlined in the examination matrix;
* Willing and able to conform to the study requirements.
Exclusion Criteria:
* • Age of patient \<45 years at the day of surgery;
* Time between first and second eye treatment: \>45 days (this accounts for bilateral implantations only);
* Subjects who underwent previous intraocular or corneal surgery other than IOL implantation;
* Subjects with diagnosed degenerative visual disorders (e.g. AMD or CME);
* Subjects in whom in-the-bag implantation was not possible;
* Subjects in whom surgical complications occurred (e.g. posterior rupture).
* Subjects showing glaucoma;
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.
What they're measuring
1
monocular Best Corrected Distance Visual Acuity (CDVA) under photopic light conditions on the first implanted eye.