A Planned Study at Multiple Sites is Being Done to Compare the Results of Two Types of Trifocal T… (NCT07232615) | Clinical Trial Compass
RecruitingNot Applicable
A Planned Study at Multiple Sites is Being Done to Compare the Results of Two Types of Trifocal Toric Intraocular Lenses Used in Cataract Surgery
Germany, India, Spain138 participantsStarted 2021-11-22
Plain-language summary
To evaluate the clinical outcomes and patient satisfaction of two commercially available trifocal toric intraocular lenses Primary Objective: To compare the distance-corrected intermediate visual acuity between the two trifocal toric intraocular lenses. Secondary Objectives: To assess and compare the safety of two trifocal toric intraocular lenses.
Who can participate
Age range
21 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
. Age of patient \>21 Years
. Patient diagnosed with cataract.
. Patient must have preoperative regular corneal astigmatism between 0.75 to 4.5 D as per corneal topography or keratometry
. Calculated IOL power is within the range of investigational IOLs.
. Patient willing to sign inform consent form.
. Clear intraocular media other than cataract.
. Female participants of childbearing potential must be willing to ensure that they use effective contraception during the study.
Exclusion criteria
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.
1This trial is comparing two types of trifocal toric intraocular lenses for cataract surgery — can you explain what the difference is between these two lens types, and which one you would recommend for my specific level of astigmatism?
2The study's main goal is to measure intermediate vision after surgery, like seeing a computer screen — how important is intermediate vision in my daily life, and is this something I should prioritize when choosing a lens?
3Since this trial is listed as Phase NA and involves a device comparison rather than a new drug, what does that mean for how much is already known about the safety of both lenses being tested?
4This is a multi-site study — where would my surgeries and follow-up visits take place, and how many appointments would I need to attend, and could that realistically fit into my schedule?
5Before considering this trial, should I discuss whether standard cataract surgery with a lens my doctor already uses regularly might be a better first option for me?
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.