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Can a single lens implant restore near and distance vision?

NCT ID NCT07790965

Disease control Sponsor: Staar Surgical Company Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

Researchers are testing a new type of implantable lens, called a diffractive trifocal phakic ICL, in adults aged 21 to 60 with myopia (nearsightedness) with or without astigmatism. The lens is surgically placed inside the eye to correct distance vision while also aiming to improve near vision, potentially reducing the need for reading glasses. This early study focuses on safety and how well the lens performs in a small group of 10 participants.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A diffractive trifocal phakic implantable collamer lens (ICL), a surgically implanted lens that corrects nearsightedness and astigmatism while also aiming to restore near vision.
What this could lead to
If it works, this lens could offer a single surgery that corrects distance vision and reduces the need for reading glasses in people with myopia and astigmatism.
What could go wrong
This is a very small early proof-of-concept study with only 10 participants, so results may not apply broadly. Surgery carries risks like infection, inflammation, or lens-related complications.
Why investors are watching

STAAR Surgical is testing a new type of implantable lens that aims to fix both near and distance vision in people with myopia, a condition the company already treats with its existing lenses. This small proof-of-concept study with 10 participants will show whether the lens works as intended, and for a small company, that early signal can shape its product pipeline and future revenue prospects.

If it works: If the lens performs well, STAAR could add a new product to its lineup that addresses a common aging vision problem, potentially expanding its market beyond its current offerings. A positive result might also strengthen investor confidence in the company's ability to innovate.

If it fails: The trial could fail to show the lens is effective or safe, which would likely set back the product's development and hurt the company's reputation. Small studies often fail, and with only 10 participants, the results may not be reliable enough to justify further investment.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Must be between the age of 21 - 60 years * Must be suitable for ICL surgery, * Must meet all unique study eligibility criteria Exclusion Criteria: * Outside the age of 21 - 60 years, * Not a suitable candidate for ICL surgery, * Does not meet all unique study eligibility criteria

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Conditions

The condition(s) this trial relates to.

astigmatism myopia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Astigmatism Myopia

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  2. A doctor treating you

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