PMCF Study on Monofocal Toric IOL (PODEYE TORIC) (NCT04744467) | Clinical Trial Compass
CompletedNot Applicable
PMCF Study on Monofocal Toric IOL (PODEYE TORIC)
Czechia12 participantsStarted 2021-05-05
Plain-language summary
This is a single-center, prospective, open-label PMCF study whereby patients undergoing routine cataract surgery will have mono- or bilateral implantation of hydrophobic acrylic monofocal toric intraocular lens PODEYE TORIC (study no. PHY2101, ClinicalTrials.gov ID: NCT04744467)
Who can participate
Age range
50 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 50 years or older on the day of screening who have clinically documented cataracts in both eyes;
* Calculated IOL power (sphere and cylinder) is within the range of the investigational IOLs;
* Regular corneal astigmatism (measured by a topographer);
* Corneal astigmatism ≥0.75 D and ≤ 4.25 D (measured by an automatic keratometer) in one or both eyes;
* Capability to understand and sign an IRB approved informed consent form and privacy authorization;
* Clear intraocular media other than cataract;
* Dilated pupil size large enough to visualize IOL axis markings postoperatively;
* Best corrected visual acuity projected to be better than 0.2 logMAR after toric IOL implantation;
* Willing and able to conform to the study requirements.
Exclusion Criteria:
* Age of patient \<50 years at the day of screening;
* Regular corneal astigmatism \<0.75 D or \>4.25 D (measured by an automatic keratometer) in both eyes
* Irregular astigmatism (measured by a topographer);
* Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal or optic disorders);
* Subjects with AMD suspicious eyes as determined by OCT examination;
* Previous intraocular or corneal surgery;
* Traumatic cataract;
* History or presence of macular edema;
* Instability of keratometry or biometry measurements; Acceptable maximum standard deviation: AL: ± 150 µm; ACD: ± 150 µm; K1 / K2: ± 0.15 D;
* Clinically significant, uncontrolled gl…
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
Rotational stability - Photograph of IOL with dilated pupil to asses IOL rotation