A tiny corneal pocket may restore Close-Up vision — no glasses needed
NCT ID NCT05115058
First seen Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time
Summary
This trial tests whether creating a small pocket inside the cornea using the SMILE module can improve near vision in people with presbyopia who want to avoid glasses. The procedure aims to increase the eye's ability to focus on close objects. Researchers are measuring how much near vision improves and whether patients are satisfied with the results.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a surgical procedure using the SMILE module to create an intrastromal pocket in the cornea
- What this could lead to
- If successful, this approach could offer a glasses-free option for improving near vision in people with presbyopia.
- What could go wrong
- This is a small, early-stage trial with no control group, and the procedure involves corneal surgery, which carries risks such as infection or visual disturbances.
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 41 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2016
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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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40 to 50 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: * patient not wishing to use glasses * weak accomodation Exclusion Criteria: * active anterior segment pathology * previous corneal or anterior segment surgery * any infection
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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
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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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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Eye Hospital Pristina
Pristina, 10000, Kosovo
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