CompletedPhase 4

Evaluation of a Monofocal Intraocular Lens

United States44 participantsStarted 2024-06-06

Plain-language summary

The aim of this study is to investigate the 3-month visual performance of the CT LUCIA 621P IOL, a hydrophobic aspheric monofocal IOL with a non-constant aspheric optic profile in adult patients 50 years of age or older who are undergoing cataract surgery.

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

. Be at least 50 years of age or older, male or female, of any race or ethnicity.
. Presenting for uncomplicated bilateral cataract surgery for age-related cataract.
. Planned bilateral cataract extraction with posterior chamber IOL implantation, via phacoemulsification with or without femtosecond laser assisted cataract surgery (FLACS).
. Bilateral implantation of a CT LUCIA 621P IOL with a dioptric power between +10.00 D and +30.00 D and a target postoperative refraction of emmetropia (0.00 ±0.50 D).
. Clear intraocular media other than cataract (i.e. no hyphema, vitreous hemorrhage)
. No visual acuity limiting pathologies other than cataract. Best corrected postoperative visual acuity potential of 20/25 or better in both eyes as estimated by potential acuity meter or surgeon estimation.
. Provide written informed consent and a signed HIPPA form.
. Availability, willingness, ability, and sufficient cognitive awareness to comply with study examination procedures and the schedule for study visits and evaluations.

Exclusion criteria

. Corneal Astigmatism of \>1.0 D.

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 best corrected distance visual acuity (CDVA)

Timeframe: Three (3) Months

Trial details

NCT IDNCT06428955

SponsorCarl Zeiss Meditec AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-02-26

View on ClinicalTrials.gov More Cataract trials