A Prospective Clinical Investigation to Evaluate the Safety and Performance of 877PTY Toric IOL f… (NCT06578884) | Clinical Trial Compass
By InvitationNot Applicable
A Prospective Clinical Investigation to Evaluate the Safety and Performance of 877PTY Toric IOL for Visual Correction of Corneal Astigmatism
Hungary100 participantsStarted 2024-04-16
Plain-language summary
Medicontur preloaded hydrophobic monofocal toric intraocular lenses (IOLs) are indicated to improve vision at far distance in adults with or without cataract and correction of pre-existing corneal astigmatism secondarily to removal of the crystalline lens.
The intraocular lens is intended to be surgically implanted into the eye with the purpose of restoring optical function in the aphakic eye to provide an optical system with high predictability of the precalculated dioptric power.
The investigation will be performed as a prospective, non-comparative, single arm study with a single center design. Patients will be enrolled who are assigned to be implanted with the 877PTY IOLs mono- or binocularly between January 2024 - June 2025.
Data from six visits will be collected:
* Visit 1: Screening and Baseline (up to 90 days prior to the surgery)
* Visit 2: IOL implantation (Day 0)
* Visit 3: Day 1 post-operatively (+/- 0 day)
* Visit 4: Day 7 post-operatively (+/- 3 days)
* Visit 5: Month 1 post-operatively (+/- 2 weeks)
* Visit 6: Month 6 post-operatively (+/- 1 month)
Who can participate
Age range
18 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:
* adult patients (18 years old and older);
* cataract and/or corneal astigmatism diagnosis;
* indication for cataract surgery or refractive lens exchange;
* recommended cylinder correction with toric IOL with cylinder power ≥1.0D;
* clear intraocular media other than cataract;
* signed informed consent form;
Exclusion Criteria:
* irregular astigmatism;
* patients who are not targeted to emmetropia (predicted residual spherical equivalent and/or astigmatism is out of the range of ±0.5D and ±0.38D respectively);
* any retinopathy or maculopathy that affects the vision;
* iris neovascularization;
* congenital eye abnormality affecting visual performance;
* advanced glaucoma;
* pseudoexfoliation syndrome affecting IOL stability;
* amblyopia;
* uveitis;
* retinal detachment;
* prior ocular surgery in personal medical history;
* irregular corneal curvature or corneal diseases affecting visual performance;
* high myopia (axial length ≥ 26,5 mm);
* inadequate visualization of the fundus on preoperative examination;
* dilated pupil size not large enough to visualize toric IOL axis markings postoperatively based on the Investigator's decision;
* eye trauma in medical history;
* instability of keratometry or biometry measurements;
* prior corneal refractive surgery such as LASIK, PRK, or SMILE;
* patients deemed ineligible by the investigator because of any systemic disease or treatment;
* pregnancy or lactation;
* current use of systemic steroids or external opht…
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.