Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Could steroid eye drops save premature Babies' sight?

NCT ID NCT05387941

Knowledge-focused Sponsor: Region Skane 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested dexamethasone eye drops in 11 premature infants at risk of blindness from retinopathy of prematurity. Researchers measured how the drug enters the blood and saliva, and monitored for side effects. The goal was to gather safety and dosing information, not to prove the drops work. The infants will be followed up at ages 2.5 and 5 years to check vision.

What this could mean

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

Active substance
dexamethasone eye drops
What this could lead to
If successful, this could help doctors understand safe dosing of steroid eye drops for premature infants, potentially reducing the need for more invasive treatments like laser or injections.
What could go wrong
This is a very small, early feasibility study with only 11 infants. It is not designed to prove the drops work, only to measure absorption and safety. Side effects like high blood pressure or slowed growth are possible, though unlikely at low doses.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

11 people

The number who actually took part.

Started

Jun 2022

Finished

Mar 2026

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

Up to 30 weeks

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: * Infants screened for retinopathy of prematurity (ROP) at Sahlgrenska University Hospital in Gothenburg, at Skåne University Hospital in Malmö and Lund and at Helsingborg Hospital. * zone I stage 1 or 2 ROP without plus disease, posterior zone II stage 2 ROP without plus disease, or zone II stage 3 ROP without plus disease. ROP needs to be documented by digital widefield photography and classification confirmed by two ophthalmologist. Exclusion Criteria: * ocular infection * systemic steroid treatment within two weeks before the start of drop treatment

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Retinopathy of prematurity are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

retinopathy of prematurity

As listed by the trial registrant

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

Retinopathy of prematurity

Contacts and locations

Locations

  • Sahlgrenska University Hospital

    Gothenburg, Västra Götaland County, 41685, Sweden

  • Skåne University Hospital

    Lund, Skåne County, 22185, Sweden

More trials for these conditions

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