CompletedNot Applicable

Retrospective, Non-interventional Clinical Investigation of the Safety and Performance of 640AD Monofocal Intraocular Lens

Hungary80 participantsStarted 2023-05-23

Plain-language summary

Medicontur hydrophilic posterior chamber monofocal intraocular lens (IOL) is indicated to improve vision at far distance in adults with cataract and/or ametropia (hyperopia, myopia), 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 study will be performed partially as a retrospective study with patients enrolled who had been implanted with 640AD IOLs mono- or binocularly between December 2021 - December 2022. Data from five visits will be collected: * Baseline preoperative (maximum 30 days prior to surgery)- retrospective * IOL implantation Day 0 - retrospective * Postoperative visit at Day 1 (+/- 0 days) - retrospective * Postoperative visit at 1 month (+/- 2 weeks) - retrospective * Postoperative visit at 12 months (+/- 3 months) - consent and prospective visit

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 males or females above 18 years of age; * Pseudophakic patients implanted with 640AD monofocal IOLs (implanted between December 2021 - December 2022); * Diagnosis of cataract and/or ametropia (hyperopia, myopia); * Subject who has signed an informed consent form. * Patients who have participated in all visits that are subject to retrospective data collection. Exclusion Criteria: * Patients who are not targeted to emmetropia ( outside -0,5 and 0,5 D) * Patients with the following condition(s) at the time of the baseline visit: * Corneal astigmatism \> 1.5 D * Uncontrolled diabetic retinopathy * Iris neovascularization * Congenital eye abnormality * Uncontrolled glaucoma * Pseudoexfoliation syndrome * Amblyopia * Uveitis * AMD (advanced AMD) * Retinal detachment * Prior ocular surgery in personal medical history * Previous laser treatment * Corneal diseases * Severe retinal diseases (dystrophy, degeneration) * High myopia * Inadequate visualization of the fundus on preoperative examination * Patients deemed by the clinical investigator because of any systemic disease * Pregnancy * Eye trauma in medical history * Current use of systemic steroids or topical ocular medication * Patients with any eye condition that could affect vision in the opinion of the investigator at the time of the 12-month follow-up: (corneal ectasia, retinal diseases, glaucoma, uveitis, dry eye or amblyopia, etc.)

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

Monocular corrected distance visual acuity (CDVA)

Timeframe: 12 months postoperatively

Trial details

NCT IDNCT06578910

SponsorMedicontur Medical Engineering Ltd

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-04-25

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