RecruitingNAINTERVENTIONAL

Phacoemulsification vs SLT as Initial Treatment for Pseudoexfoliation Glaucoma

This research study, called the Canadian Pseudoexfoliation Glaucoma Study 1, aims to find the best first treatment for people newly diagnosed with pseudoexfoliation glaucoma, a condition where pressure inside the eye can be too high. Doctors are comparing two treatments: a laser procedure called Selective Laser Trabeculoplasty (SLT) and a cataract operation called Phacoemulsification. Participants will be randomly assigned to receive one of these treatments. The main goal is to see which treatment helps patients keep their eye pressure down without needing additional eye drops after two years. The study will also look at how much eye pressure reduces, how long it takes before eye drops are needed, how treatments affect vision, and any side effects. This will help doctors understand the most effective ways to manage this type of glaucoma.

At a glance

Status

Recruiting

Phase

Sponsor

Nova Scotia Health Authority

Enrolment target

200

Start

10 Oct 2022

Estimated completion

01 Aug 2033

Pseudoexfoliation Glaucoma

What is this study about?

When you have a condition called pseudoexfoliation glaucoma, it means the pressure inside your eye (called intraocular pressure or IOP) can be too high, which might damage your eyesight over time. Doctors often recommend certain treatments to help lower this pressure. This particular study is trying to understand which of two initial treatments works best for people newly diagnosed with this type of glaucoma.

The two treatments being compared are Selective Laser Trabeculoplasty (SLT) and Phacoemulsification (often shortened to PHACO). SLT is a laser procedure that helps the eye’s natural drainage system work better to reduce pressure. Phacoemulsification is actually a common operation to remove cataracts, which are cloudy areas in the eye’s lens. It's thought that removing the cataract might also help lower eye pressure in some cases.

Researchers want to see if one of these treatments is more effective at controlling eye pressure in the long term, especially in people who also have early, mild cataracts that they might not even notice yet. The goal is to identify which treatment helps more patients avoid needing daily eye drops to manage their eye pressure after two years, and to find out how these treatments affect people's vision and overall eye health.

Key takeaways

Compares two treatments for pseudoexfoliation glaucoma: laser (SLT) and cataract surgery (PHACO).
Aims to find which treatment best lowers eye pressure and reduces the need for eye drops.
Specifically for newly diagnosed patients who also have mild cataracts.
Participants will be followed for two years, with longer-term record reviews.
Helps doctors understand the most effective initial approach for this glaucoma type.

Who may be eligible?

To be part of this study, you would generally need to be diagnosed with pseudoexfoliation syndrome and have a doctor decide that your eye pressure needs to be lowered. You should also have early, symptom-free cataracts. This study is for people aged 50 and older.

However, some things would mean you couldn't join. For example, if you've had a procedure to lower your eye pressure before, like previous laser treatment or surgery. Also, if you've been using eye drops to lower your pressure for more than six months, you wouldn't be able to take part. Conditions like other serious eye problems (like severe inflammation or certain types of glaucoma) or if your eye pressure is extremely high (above 36 mmHg) or if your vision is already very damaged, would also prevent your participation.

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 50 years old or older?
Have you been diagnosed with pseudoexfoliation syndrome?
Has your eye doctor decided your eye pressure needs treatment?
Do you have early, mild cataracts that don't cause symptoms?
Have you NOT had previous eye pressure-lowering surgery or laser treatment?
Have you NOT used eye drops for glaucoma for more than six months?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be randomly assigned to receive one of two treatments: either a laser procedure called SLT or a cataract operation called Phacoemulsification. This is similar to tossing a coin to decide which group you are in. After your initial treatment, you'll have regular check-ups with the study doctors over two years. During these visits, your eye pressure will be carefully monitored to make sure it stays within a safe range, as set by eye care guidelines.

If your eye pressure isn't reaching the target level with the initial treatment, you might be given eye drops to help lower it. The study will mainly look at whether you need these pressure-lowering eye drops after two years. They'll also check your vision, ask about how your eyes feel, and look for any side effects. To understand the long-term effects of the treatments, the doctors will also review your medical records five and ten years after you joined the study, to see how your eyes are doing.

Potential risks and benefits

Taking part in any study involves careful consideration. Potential benefits might include receiving either a laser treatment or cataract surgery at an early stage, which could help manage your eye pressure and potentially reduce the need for daily eye drops. Both treatments are established procedures. Potential risks are generally associated with the specific treatment you receive, such as possible side effects from laser treatment or surgery, which your doctor will explain in detail. It’s important to remember that you are free to withdraw from the study at any time without affecting your usual medical care.

Locations (1)

Nova Scotia Health
Verified postcode
Halifax, Canada· Recruiting

Common questions

What is pseudoexfoliation glaucoma?

It's a type of glaucoma where flaky material builds up in the eye, which can block the eye’s drainage system and cause high pressure, potentially damaging vision.

What is Phacoemulsification (PHACO)?

This is a common operation to remove cataracts, which are cloudy areas in the eye's lens. It can sometimes help to lower eye pressure too.

What is Selective Laser Trabeculoplasty (SLT)?

SLT is a type of laser treatment that helps the eye's natural drainage channels work better, which can reduce pressure inside the eye.

Will I have to pay for the treatments?

Generally, in clinical trials, the treatments being studied are provided as part of your participation, but it's important to confirm this with the study team.

What if my eye pressure doesn't get low enough?

If your eye pressure isn't at the target level after the initial treatment, you will be given eye drops to help lower it, similar to standard care.

How to find out more

Marcelo Nicolela, MD

nicolela@dal.ca 902-473-2839 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.