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New microscope camera could make eye surgery safer and more precise

NCT ID NCT03713268

Knowledge-focused Sponsor: Duke University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a special microscope that takes live 3D images inside the eye during surgery. It aims to help surgeons see better when treating conditions like retinal detachment, macular holes, and cataracts. About 262 people will take part, including healthy volunteers and surgical patients. The goal is to see if this imaging tool improves surgical accuracy and outcomes.

What this could mean

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

Active substance
Microscope integrated optical coherence tomography (MIOCT) device
What this could lead to
If successful, this could improve surgical precision and outcomes for various eye surgeries by providing real-time 3D imaging during procedures.
What could go wrong
This is an early-stage study focused on imaging quality, not treatment outcomes. The device may not improve surgical results or could be difficult to use in practice.

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.

Participants

About 262 people

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

Started

Sep 2018

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

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.

Who is studied

262 subjects enrolled in 3 groups as follows: 1. Healthy Controls: 50 subjects 2. Surgeons as research subjects performing randomized testing in wet lab: 22 subjects 3. Surgical patients as research subjects for application to ocular vitreoretinal and anterior segment surgery: 190 subjects

Ages

4 weeks and older

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: 1. Healthy controls: Healthy eyes without known disease: refractive error including myopia and non-significant cataract is allowed. For selected testing pseudophakia is allowed. 2. Surgeons as research subjects: Adult (≥18 years old) 3. Surgical patients (vitreoretinal surgery): Patients undergoing examination under anesthesia or surgery for vitreoretinal diseases 4. Surgical patients (anterior segment surgery-glaucoma, ocular surface or strabismus requiring extraocular muscle surgery): Include both adults and children. Patient undergoing primary, elective minimally invasive glaucoma surgery, ocular surface surgery, or strabismus surgery. Exclusion Criteria: 1. Healthy controls: Any ocular disease that restricts the ability to perform OCT scanning. Conflict of interest with investigators/study personnel, e.g. a student in the lab of an investigator. 2. Surgeons as research subjects: no specific exclusion criteria. 3. Surgical patients (vitreoretinal surgery): Neonates (\< 4 weeks of age) and patients with any ocular disease that restricts the ability to perform OCT scanning. 4. Surgical patients (anterior segment surgery-corneal and cataract diseases): Pediatric patients: The cornea and cataract surgery studies will be restricted to adults (≥ 18 years). Children do not have cataract surgery typically by residents and therefore would not fit our study design. Similarly pediatric corneal transplants are very rare.

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Conditions

The condition(s) this trial relates to.

cataract diabetic retinopathy eye neoplasm glaucoma macular holes ocular cancer preretinal fibrosis retinal detachment retinal disorder retinal perforation strabismus

As listed by the trial registrant

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

Cataract Diabetic retinopathy Epiretinal membrane Healthy Macular holes Ocular tumor Preretinal fibrosis Retinal detachment Retinal disease Strabismus

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

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

    Open the record ↗

  3. 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

  • Duke University Eye Center

    RECRUITING

    Durham, North Carolina, 27710, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.