CompletedNot Applicable

Clinical Performance of a Phakic Intraocular Lens (IOL)

Belgium, Spain41 participantsStarted 2018-03-20

Plain-language summary

This study will evaluate the clinical performance of a phakic intraocular lens (IOL) for the improvement of Uncorrected Near Visual Acuity (UCNVA) in subjects who require between +1.00 and +2.50 Reading Add.

Who can participate

Age range

40 Years – 60 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

. Must be able to read, understand and provide written informed consent,
. Willing and able to comply with all treatment and follow-up study related procedures,
. 40 - 60 years of age at time of surgery if require spherical lens powers from -0.50 D to -18.00 D,
. 35 - 45 years of age at time of surgery if require a spherical lens power from 0.0 D to +3.00 D,
. Preoperative refraction fully correctable with available lens powers, with ≤ 0.75 D preoperative refractive and residual cylinder,
. \< 0.75 D spherical equivalent difference between cycloplegic and manifest refractions,
. Stable correction (± 0.50 D) as determined by manifest refraction spherical equivalent (MRSE),
. Best Corrected Distance Visual Acuity 20/20 or better in both eyes,

Exclusion criteria

. Participation in a clinical trial within 30 days prior to entry into this study and/or during the period of study participation,
. Previous intraocular or corneal surgery in either eye, including refractive surgery,

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

Number of Eyes With Monocular Uncorrected Near Visual Acuity of 20/40 or Better at 40 cm 6 Months After Implantation

Timeframe: 6 months

Trial details

NCT IDNCT03499821

SponsorStaar Surgical Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-07-09

Results submitted2022-05-20

View on ClinicalTrials.gov More Presbyopia trials