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A simple surgical tweak might stop eyelid drooping after face trauma

NCT ID NCT07775417

Disease control Sponsor: Minia University Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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)
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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
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Status unknown
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First seen Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This trial tests whether adding a preventive step during orbital fracture surgery can reduce the chance of the lower eyelid turning outward (ectropion), a common complication. Adults with orbital floor fractures will be randomly assigned to receive the standard subciliary approach alone, or with one of two extra techniques: lateral canthopexy or orbicularis oculi suspension. The study will compare how often ectropion occurs in each group and measure eyelid position over time to see which approach works best.

What this could mean

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

Active substance
Surgical techniques: subciliary approach alone, with lateral canthopexy, or with orbicularis oculi suspension
What this could lead to
If successful, this could identify a simple surgical step that reduces the risk of eyelid drooping after orbital fracture repair, improving patient outcomes.
What could go wrong
This is a small, early-stage trial with only 30 participants, so results may not apply broadly. Surgical techniques carry inherent risks like infection or scarring.

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 30 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Nov 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.

Ages

18 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: * Systemically healthy patients aged 18 years or older, with no history of chronic or uncontrolled systemic diseases. * Patients with primary orbital trauma requiring surgical treatment through a standardized subciliary approach, presenting with orbital floor fractures with or without associated lateral orbital rim fractures involving the lateral canthal tendon region, and without associated zygomaticomaxillary complex (ZMC) fractures. Exclusion Criteria: * Secondary orbital trauma (revision cases or patients with previous orbital trauma). * Previous lower eyelid surgery. * Pre-existing eyelid malposition (ectropion or entropion) or other pre-existing lower eyelid or lateral canthal abnormalities. * Uncontrolled systemic conditions that may affect wound healing, eyelid integrity, or lower eyelid laxity, including uncontrolled diabetes mellitus, immunocompromised status, chronic corticosteroid therapy, or collagen vascular diseases. * Previous radiotherapy to the orbital or facial region.

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Conditions

The condition(s) this trial relates to.

ectropion Orbital Fractures

As listed by the trial registrant

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

Orbital floor fractures Orbital fractures

How to take part

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  1. The official record

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