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Could a tiny corneal implant replace reading glasses?

NCT ID NCT04465409

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tests a new device called CorVision, a tiny lens made from collagen that is placed inside the cornea to improve near vision in people with presbyopia (age-related difficulty seeing up close). 110 adults aged 40-65 will receive the implant in one eye through a minimally invasive laser procedure. Researchers will check safety (e.g., implant rejection) and whether near vision improves enough to reduce dependence on reading glasses over 12 months.

What this could mean

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

Active substance
CorVision bioengineered corneal inlay
What this could lead to
If successful, this could offer a minimally invasive, reversible option to reduce or eliminate the need for reading glasses in people with presbyopia.
What could go wrong
This is an early-stage, non-comparative study with no control group, so results may not prove superiority over existing treatments. Risks include implant rejection, corneal clouding, or inflammation requiring removal.

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

110 people

The number who actually took part.

Started

Mar 2020

Expected to finish

Jun 2026

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

40 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Signed and dated informed consent * Presbyopic adults, Male or female between 40-65 years of age who need from +1.25 D to +3.50 D of reading addition in the non- dominant eye to improve near visual acuity by at least one line or more. * Manifest refraction spherical equivalent (MRSE) between -0.75 and +1.50 D with ≤1.5 D of refractive cylinder in the non-dominant eye. * Stable refraction, i.e. MSRE within 0.50 D over prior 12 months in the non-dominant eye. * Corrected distance visual acuity CDVA ≥ 0.7 in the dominant and non-dominant eye Exclusion Criteria: * Anterior segment pathology in the non-dominant eye. * Signs or symptoms of clinically significant cataracts in the non-dominant eye. * Residual, recurrent, active ocular or uncontrolled eyelid disease, or any corneal abnormality (including endothelial dystrophy, recurrent corneal erosion, etc.) in the nondominant eye. * Visually significant macular pathology * Central corneal thickness \<470 microns in either eye and corneal curvature ≥ 50D * Corneal ectasia, keratoconus or form frust keratoconus * Clinically significant dry eye disease * Any prior ocular surgery in the non-dominant eye. * History of herpes zoster or herpes simplex keratitis in the non-dominant eye. * Inability of patient to understand the study procedures and thus inability to give informed consent. * Participation in another clinical study within the last 3 months * Already included once in this study (can only be included for one treated eye). * General history judged by the investigator to be incompatible with the study (e.g., life- * threatening patient condition, other condition where postoperative follow-up may be difficult). * known uncontrolled diabetes or other neuro-degenerative disorder (as corneal nerves can be affected leading to impaired wound healing)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Gemini Eye Clinics

    Zlín, 760 01, Czechia

More trials for these conditions

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