AuthorisedTherapeutic use (Phase IV)Interventional

Selective laser trabeculoplasty versus eye drops for first line treatment of exfoliation ocular hypertension or glaucoma: a randomised clinical trial

This research is investigating the best way to treat a specific eye condition called exfoliation ocular hypertension or glaucoma. This condition causes high pressure inside the eye, which can damage your sight over time. The study is comparing two main treatments: a gentle laser procedure called selective laser trabeculoplasty (SLT) and daily eye drops. We want to find out if using eye drops in addition to the laser treatment helps control eye pressure faster. Researchers will also be checking for side effects like dry eyes, how long the laser treatment works, and whether patients eventually need surgery for their glaucoma. This is a later-stage study, meaning these treatments are already in use, but we're trying to refine how they are best applied.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

HUS-Yhtymae

Enrolment target

112

Start

19 Dec 2024

Glaucoma

What is this study about?

This study is focused on a common eye condition called glaucoma, specifically a type known as exfoliation ocular hypertension or glaucoma. In simple terms, this means you have high pressure inside your eye, which can, over time, harm the nerve that connects your eye to your brain. If left untreated, this can lead to vision loss. The good news is that there are treatments to lower eye pressure and protect your sight.

In this research, doctors are comparing two main ways to treat this high eye pressure: a gentle laser procedure called Selective Laser Trabeculoplasty (SLT) and daily eye drops (Taflotan®). Both of these treatments are already used to help people with glaucoma. The main question this study wants to answer is whether adding eye drops to the laser treatment helps lower eye pressure faster and more effectively right from the start.

Apart from how quickly the treatment works, the study will also be looking at other important things. For example, they'll check if participants experience dry eyes with the treatments, how well the laser treatment continues to work over a longer period, and importantly, whether patients eventually need more serious surgery for their glaucoma. Understanding these points will help doctors decide the best first-step treatment for people with this condition.

Key takeaways

The study compares a laser treatment with eye drops for a type of glaucoma.
It aims to see if adding eye drops speeds up treatment success from the start.
Researchers will check for dry eyes, long-term effectiveness, and need for surgery.
This is for people with high eye pressure or glaucoma caused by 'exfoliation'.
Both treatments are already used in medical practice.

Who may be eligible?

To be able to take part in this study, you need to be at least 18 years old. There's no upper age limit, meaning older adults are welcome to participate too. The study is open to both men and women.

Generally, you would be considered if you have been diagnosed with exfoliation ocular hypertension or glaucoma, as this is the specific condition the study is looking into. Your eye doctor will be able to tell you if your particular情况 makes you suitable for this research.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been told you have exfoliation ocular hypertension or glaucoma?
Are you able to attend follow-up appointments?
Are you comfortable potentially receiving either eye drops or a laser treatment?

Answer every question to see your result.

What does participation involve?

The detailed involvement for this study isn't fully outlined here, but typically, taking part in a clinical trial like this would involve a series of visits to the clinic. You would likely undergo eye examinations to measure your eye pressure, check for dry eyes, and assess other aspects of your eye health. If you are assigned to receive eye drops, you would be provided with them and instructed on how and when to use them. If you are assigned to the laser treatment, you would have that procedure. There would be follow-up appointments to monitor your progress, check your eye pressure, and see how you are responding to the assigned treatment. The total duration of your participation would depend on the long-term follow-up needed.

Potential risks and benefits

Taking part in this study could potentially benefit you by providing close monitoring of your eye condition and access to treatments aimed at lowering eye pressure to protect your vision. However, like all medical treatments, there can be potential risks. Eye drops can sometimes cause side effects like discomfort or dry eyes, and the laser procedure, while generally safe, also carries a small risk of temporary side effects or needing further treatment. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Finland

Common questions

What is glaucoma?

Glaucoma is an eye condition where the nerve connecting your eye to your brain gets damaged, often due to high pressure inside your eye. This can lead to vision loss if not treated.

What is 'exfoliation ocular hypertension'?

This is a specific type of high eye pressure or glaucoma where tiny flakes from inside your eye can block the drainage system, causing pressure to build up.

What is SLT?

SLT stands for Selective Laser Trabeculoplasty. It's a gentle laser treatment used to help lower eye pressure by improving how fluid drains from your eye.

Are the treatments in this study new?

No, both the laser treatment and the eye drops are already established treatments for glaucoma. This study is looking at the best way to use them together or individually as a first-line treatment.

Will I have to pay to be in the study?

Typically, participation in clinical trials in the UK means that study-related treatments and visits are covered. It's always best to confirm this with the research team.