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One shot to soothe: new injection may replace eye drops after cataract surgery

NCT ID NCT06497699

Disease control Sponsor: Ocumension Therapeutics (Shanghai) Co., Ltd Source: ClinicalTrials.gov ↗

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested a single injection of dexamethasone (Dexycu) given during cataract surgery to control eye inflammation. Researchers compared 263 patients who received the injection to an external control group. The main goal was to see how many patients had no signs of inflammation (anterior chamber cells) 8 days after surgery. The approach aims to simplify post-surgery care by replacing multiple eye drops with one injection.

What this could mean

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

Active substance
dexamethasone injection (Dexycu)
What this could lead to
If successful, this could confirm a convenient single-injection option to manage post-surgery eye inflammation, reducing the need for eye drops.
What could go wrong
This is a real-world study, not a blinded trial, so results may be less reliable. Inflammation control may not be better than standard care, and side effects like increased eye pressure are possible.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

263 people

The number who actually took part.

Started

Oct 2021

Finished

Dec 2023

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

40 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: * Subjects must be able to understand and sign the informed consent form and be able to follow the study procedures. * Male or female subjects over 40 years of age who are scheduled to undergo cataract phacoemulsification surgery combined with intraocular lens implantation. Exclusion Criteria: * Known hypersensitivity to dexamethasone or any component of the Dexycu. * History of intraocular inflammation of any cause in either eye, presence of corneal abnormalities or malnutrition. * Have high intraocular pressure, with an IOP(intraocular pressure) of \> 21 mmHg in the test eye at screening, regardless of whether receiving anti-glaucoma monotherapy therapy. * Posterior capsule rupture or lens dislocation, anterior vitreal membrane rupture, vitreous prolapse and intraoperative floppy iris syndrome during cataract surgery. * Other conditions that the investigator considers inappropriate to participate the study.

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Conditions

The condition(s) this trial relates to.

cataract Inflammation inflammatory disease

As listed by the trial registrant

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

Cataract Inflammation

Contacts and locations

Locations

  • Boao Super Hospital

    Bo'ao, China

  • Hainan Traditional Chinese Medicine Hospital

    Haikou, Hainan, China

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