A tiny sheet implanted in the eye aims to reverse nearsightedness damage

NCT ID NCT05658237

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 21, 2026 ยท Last updated Sep 21, 2026

Summary

Researchers are testing whether a thin sheet called PAL-222 can repair damage to the retina in people with severe nearsightedness. The condition, myopic chorioretinal atrophy, causes patches of the light-sensing tissue at the back of the eye to waste away. In this small study, 10 adults with the condition receive the implant in one eye through a standard eye surgery called pars plana vitrectomy. The untreated eye serves as a comparison to see whether the implant changes the size of the damaged areas.

What this could mean

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

Active substance
a sheet implant called PAL-222 placed under the retina
What this could lead to
If it works, the implant could offer a way to repair or slow the retinal damage that steals central vision in people with severe nearsightedness.
What could go wrong
This is a very early, tiny study of 10 people, so most treatments at this stage fail or help only a few. Eye surgery carries risks of infection, bleeding, or further vision loss.

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.

Started

Feb 2023

Expected to finish

Mar 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

20 years and older

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: * Patients aged 20 years or older at the time of consent acquisition * Patients with binocular intensity myopia (myopia of -6.0 diopter (D) or more) or patients with axial length (26 mm) or more equivalent to -6.0 D * Corrected characters of the test eye patients with visual acuity of less than 60 characters (equivalent to decimal visual acuity 0.32) * Patients diagnosed with binocular myopic chorioretinal atrophy and having atrophy of 1 papillary diameter (1.5 mm) or more in the area within 2 papillary diameter (3.0 mm) including the fovea centralis in the subject eye * Patients without active choroidal neovascularization Exclusion Criteria: * Patients with abnormal findings that pose a problem in clinical trial participation in screening tests. * Patients with positive hepatitis B surface (HBs) antigen, Hepatitis C virus (HCV) antibody, Human immunodeficiency virus (HIV) antibody, Human T-lymphotropic virus type 1 (HTLV-1) antibody, syphilis serum reaction * Patients with allergies to human serum albumin antibiotics, trypsin * Patients with eye infections * Patients with other retinal diseases (diabetic retinopathy, hypertensive retinopathy, vascular occlusion) * Patients with confirmed optic nerve atrophy * Patients with glaucoma who cannot control intraocular pressure * Patients with findings associated with myopic traction macular disease (apparent posterior macular tumor, vitreous macular traction, retinal separation, macular hole detachment, macular hole) * Patients with atrophy in all areas of the circle within 3 papilla diameter (4.5 mm) (9.0 mm in diameter) from the fovea * Patients with corrected visual acuity of control eye 0.08 or less * Patients with severe blood disorders, heart failure, liver disorders, and renal disorders * Patients diagnosed with malignant tumor within 5 years or patients requiring treatment * Pregnant women, lactating women, patients wishing to become pregnant during the trial period * Patients who cannot discontinue anticoagulants or antiplatelet drugs before the trial * Patients with drug addiction or alcoholism * Patients receiving treatment with vascular endothelial growth factor inhibitor or photodynamic therapy within 4 months prior to transplantation for test eye or 2 months for reference eye. * Patients who underwent eye surgery (excluding lens reconstruction) within 3 months before transplantation. In the case of cataract surgery, if 7 days or more have passed since surgery and postoperative inflammation is stable, registration is possible.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Myopic chorioretinal atrophy are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

As listed by the trial registrant

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

Contacts and locations

Locations

  • Nagoya city university hospital

    Nagoya, Aichi-ken, Japan

  • Yamguchi University Hospital

    Ube, Japan