CompletedNot Applicable

Multicenter Clinical Trial of a Phakic Implantable Collamer® Lens (ICL)

United States327 participantsStarted 2020-01-30

Plain-language summary

This objective of this study is to evaluate the safety, and to collect supportive data on effectiveness of the EVO/EVO+ Visian® Implantable Collamer® Lens (ICL) in study participants who have a diagnosis of myopia or myopia with astigmatism. Primary study analysis will be evaluated when 300 primary eyes complete 6 months of follow-up. Final study analysis will be assessed when all treated eyes complete 36 months of follow-up.

Who can participate

Age range

21 Years – 45 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: * Moderate to high myopia or myopic astigmatism correctable with available EVO/EVO+ ICL powers. * Stable refractive history within 0.50 D each cylinder and spherical equivalent (SE) for 1 year prior to implantation. * Able and willing to return for scheduled follow-up examinations after surgery. * Able to read, understand and provide written informed consent on the Institutional Review Board (IRB)-approved informed consent form (ICF) and provide authorization as appropriate for local privacy regulations. * Other protocol-specified inclusion criteria may apply. Exclusion Criteria: * Insulin-dependent diabetes or diabetic retinopathy. * History of previous ocular surgery. * Cataract of any grade. * Monocular. * Pregnant or nursing women, or those who plan to become pregnant over the course of this clinical study. * Other protocol-specified exclusion criteria may apply.

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 Primary Eyes Requiring Peripheral Iridotomy (PI)

Timeframe: 6 Months

Endothelial Cell Density (ECD) Change in Primary Eyes.

Timeframe: 6 Months

Endothelial Cell Density (ECD) <1000 Cells/mm² in Primary Eyes.

Timeframe: 6 months

Endothelial Cell Density (ECD) <1500 Cells/mm² in Primary Eyes.

Timeframe: 6 months

Number of Ocular Adverse Events (AEs) in Primary Eyes.

Timeframe: 6 Months

Trial details

NCT IDNCT04283149

SponsorStaar Surgical Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-04-05

Results submitted2022-04-08

View on ClinicalTrials.gov More Myopia trials

Plain-language summary

Who can participate

Age range

21 Years – 45 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.

What they're measuring

Number of Primary Eyes Requiring Peripheral Iridotomy (PI)

Timeframe: 6 Months

Endothelial Cell Density (ECD) Change in Primary Eyes.

Timeframe: 6 Months

Endothelial Cell Density (ECD) <1000 Cells/mm² in Primary Eyes.

Timeframe: 6 months

Endothelial Cell Density (ECD) <1500 Cells/mm² in Primary Eyes.

Timeframe: 6 months

Number of Ocular Adverse Events (AEs) in Primary Eyes.

Timeframe: 6 Months