Study Comparing Laser Treatment and Tafluprost Eye Drops for Patients with Exfoliation Glaucoma or Ocular Hypertension

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What is this study about?

This clinical trial is focused on studying two eye conditions: glaucoma and ocular hypertension. These conditions involve increased pressure in the eye, which can lead to vision problems if not treated. The study is comparing two treatments for these conditions: a laser procedure called Selective Laser Trabeculoplasty (SLT) and eye drops. The eye drops being tested contain a medication called tafluprost, which is used to lower eye pressure.

The purpose of the study is to determine if the SLT laser treatment is as effective as the eye drops when used as the first treatment option for a specific type of glaucoma known as exfoliation glaucoma. Participants in the study will be randomly assigned to receive either the laser treatment or the eye drops. The study will monitor the effectiveness of these treatments over a period of time, looking at factors such as the need to add more eye drops, eye dryness, and changes in eye pressure.

The study will also assess the long-term success of the SLT treatment and whether there is a need for further glaucoma surgery. Participants will be followed for a period to observe these outcomes. The goal is to provide valuable information on the best initial treatment approach for managing exfoliation glaucoma and ocular hypertension.

1 initial assessment

Upon joining the trial, an initial assessment is conducted to confirm eligibility. This includes verifying age between 50 and 100 years, the ability to participate for 12 months, and a diagnosis of exfoliation glaucoma or ocular hypertension with eye pressure less than 35 mmHg.

2 randomization

Participants are randomly assigned to one of two groups: one receiving selective laser trabeculoplasty (SLT) and the other receiving eye drops as the first line of treatment.

3 treatment administration

For those in the eye drops group, the medication used is tafluprost, administered as eye drops. The dosage is 15 micrograms per milliliter, applied once daily in the evening.

Participants in the SLT group undergo a laser procedure aimed at reducing eye pressure.

4 follow-up visits

Regular follow-up visits are scheduled to monitor eye pressure, assess for any side effects such as eye dryness, and evaluate the overall success of the treatment.

5 evaluation of treatment efficacy

The primary goal is to determine if the SLT laser treatment is as effective as the eye drops in managing exfoliation glaucoma.

Secondary evaluations include monitoring for eye dryness, changes in eye pressure, and the long-term success of SLT treatment, as well as the potential need for glaucoma surgery.

6 completion of trial

The trial is expected to continue until December 1, 2030. Participants will be monitored throughout the trial period to gather comprehensive data on the effectiveness and safety of the treatments.

Who Can Join the Study?

Provide informed consent, which means you agree to participate after understanding the study details.
Be between the ages of 50 and 100 years.
Be able to attend the study for a period of 12 months.
Have a condition called exfoliation, which is related to the eye.
Have been newly diagnosed with exfoliation glaucoma or have ocular hypertension (high eye pressure) of 24 mmHg or more, according to the European Glaucoma Society guidelines.
Have an eye pressure that is less than 35 mmHg.

Who Cannot Join the Study?

Patients who have any other eye condition besides glaucoma that might affect the study results.
Patients who have had previous eye surgery that could interfere with the study.
Patients who are currently using medications that might affect the study results.
Patients who have a history of severe allergic reactions to medications used in the study.
Patients who are pregnant or breastfeeding.
Patients who are unable to follow the study procedures or attend the required visits.
Patients who have participated in another clinical trial within the last 30 days.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Hpuuqogr Ubllrcdnli Crkicof Haqwdyqy	Helsinki	Finland

Trial status

Country	Status	Recruitment Start
Finland	Not yet recruiting	03.11.2020

Trial locations

Investigated drugs:

Tafluprost

Selective Laser Trabeculoplasty (SLT) is a type of laser treatment used to lower pressure in the eye. It is often used for patients with glaucoma or high eye pressure. The laser helps to improve the drainage of fluid from the eye, which can reduce the pressure and help prevent damage to the optic nerve.

Eye Drops are medications used to lower eye pressure in patients with glaucoma or ocular hypertension. These drops work by either reducing the amount of fluid produced in the eye or by helping the fluid drain out of the eye more effectively. They are often used as a first-line treatment to manage eye pressure and prevent vision loss.

Investigated diseases:

Glaucoma

Glaucoma – Glaucoma is a group of eye conditions that damage the optic nerve, which is crucial for good vision. This damage is often caused by abnormally high pressure in the eye. Over time, increased pressure can erode the optic nerve tissue, which may lead to vision loss or even blindness if not managed. The progression of glaucoma is typically slow, and it may not show symptoms until significant damage has occurred. It is most commonly seen in older adults, but it can occur at any age. Regular eye exams are important to detect the condition early and prevent further damage.

Trial ID:

2024-520083-33-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Laser Treatment and Tafluprost Eye Drops for Patients with Exfoliation Glaucoma or Ocular Hypertension

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?