Could a micro implant replace reading glasses?
NCT ID NCT07637500
First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 2 times
Summary
This study tests a small device called the VisAbility™ Micro Insert System, which is placed in the eye to help people with presbyopia (age-related trouble seeing up close) read without glasses. It involves 33 adults aged 45 to 60 and will track safety and vision improvement over 12 months. The goal is to see if the implant can improve near vision while keeping distance vision sharp.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- VisAbility™ Micro Insert System (a tiny implant placed in the eye)
- What this could lead to
- If it works, this could offer a new option for people with presbyopia to see up close without reading glasses.
- What could go wrong
- This is a small, early-stage trial with only 33 participants, so results may not apply to everyone. Eye surgery always carries risks like infection or vision changes.
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
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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
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About 33 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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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
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45 to 60 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: 1. Subjects must be between ages of 45 to 60 at the time of enrolment. 2. Subjects must have best corrected distance visual acuity (BCDVA) of 20/20 in each eye. 3. Subjects must have distance corrected near visual acuity (DCNVA) @ 40 cm of 20/50, 20/63 or 20/80 in each eye. 4. Subjects must have binocular distance corrected near visual acuity (DCNVA) @ 40 cm of 20/50, 20/63 or 20/80. Exclusion Criteria: 1. Subjects where either pupil has a baseline percent change from scotopic to photopic of less than 30% or an absolute difference of less than 1.00 mm between scotopic and photopic pupil size as measured by the NeurOptics Pupillometer. 2. Subjects with ocular inflammation, chronic uveitis, or other recurrent anterior or posterior segment inflammatory conditions in either eye; subjects with any ocular or systemic disease(s) posting a significant risk for ocular inflammation, including but not limited to autoimmune disorders (e.g., rheumatoid arthritis, ankylosing spondylitis, Reiter's syndrome, ulcerative colitis, Crohn's disease, psoriasis, sarcoidosis, Behcet's disease), infections (toxoplasmosis, cat-scratch fe ver, West Nile virus, syphilis, tuberculosis, herpes zoster, herpes simplex, adenovirus), ocular trauma, or gout. 3. Subjects with scleral thickness of less than 530 microns as measured 3.5 to 4.0 mm posterior to the superior temporal quadrant limbus in either eye. 4. Subjects with a history of any prior intraocular procedure (e.g., corneal transplant, filtering procedures for glaucoma, vitrectomy, retinal detachment repair, cataract surgery) or any prior refractive procedure (e.g. LASIK, surface excimer, or incisional surgery) in either eye.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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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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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Refocus Clinical Site
RECRUITINGBochum, Germany
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Universitäts-Augenklinik Heidelberg
RECRUITINGHeidelberg, Germany
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Eye scans as a window to the body: study probes retinal imaging across diseases
- Can newer cataract lenses keep vision clear for years?
- Which multifocal lens delivers sharper sight? a Head-to-Head test
- A simple fix: could reading glasses boost factory output?
- A simple pair of glasses could keep thousands of workers employed