RecruitingPHASE3INTERVENTIONAL

Clarifying the Optimal Application of SLT Therapy Trial

This study is investigating a laser treatment called SLT, used for people with glaucoma or high pressure in their eyes. The main goal is to find out if using a lower energy level for the SLT treatment works just as well as the standard energy level. Researchers also want to see if having a low-energy SLT treatment once a year can prevent or delay the need for daily eye drops more effectively than waiting until the previous SLT treatment wears off. This is a Phase 3 trial, meaning it's well into the testing process to confirm the benefits and safety of this approach.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

University of Pittsburgh

Enrolment target

790

Start

07 Sep 2021

Estimated completion

31 Aug 2027

Glaucoma and Ocular Hypertension

What is this study about?

This study is called the "Clarifying the Optimal Application of SLT Therapy Trial" and it's all about improving how we treat glaucoma and a related condition called ocular hypertension (which means high pressure in the eye). Both of these conditions can, if left untreated, lead to vision problems.

The main treatment we're looking at here is called SLT, which stands for Selective Laser Trabeculoplasty. It's a type of laser treatment that helps lower the pressure inside your eye. In this study, we're comparing two ways of doing SLT: one using a lower energy setting and another using the standard energy setting. The goal is to see if the lower energy treatment works just as well. If it does, it might mean less impact on the eye over time.

Another important question the study aims to answer is whether having a low-energy SLT treatment once a year can make a bigger difference than waiting for the treatment to wear off before having it again. The hope is that this regular, low-energy approach could help people avoid or delay needing to use daily eye drop medications, which can sometimes be inconvenient or cause side effects. This research could help doctors decide the best way to use SLT to protect people's vision.

Key takeaways

It's a study looking at laser treatment (SLT) for high eye pressure and glaucoma.
Compares low-energy SLT to standard-energy SLT.
Aims to see if yearly low-energy SLT can reduce the need for eye drops.
Participation involves eye exams and laser treatment.
You must be 18 or older with specific types of glaucoma or high eye pressure.
It's a Phase 3 trial, meaning it's a later stage of research.

Who may be eligible?

To join this study, you need to be at least 18 years old and generally healthy. You would need to have either high pressure in your eyes (ocular hypertension) that puts you at higher risk, or a type of glaucoma called primary open-angle glaucoma that is either mild or moderate. Importantly, doctors will check your vision, and it needs to be good enough (at least 6/60 on the UK scale or 20/200 on the US scale) in each eye.

There are also some reasons why you might not be able to join. For example, if you've already had eye surgery in the last six months, had any previous laser treatment to lower eye pressure, or if you've used eye drops for pressure for more than six months in the last five years. People with more severe glaucoma, other types of glaucoma, or very high eye pressure (over 35 mmHg) won't be able to take part. Also, if you have certain other eye problems, are pregnant, or planning to become pregnant in the next four years, you wouldn't qualify. You also need to be able to attend all the study appointments.

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?
Do you have high eye pressure or mild/moderate glaucoma?
Has it been more than six months since you last used eye pressure drops (if you have used them in the last 5 years)?
Have you NOT had eye surgery or laser treatment for eye pressure in the last 6 months?
Are you able to attend all clinic appointments regularly?
Are you NOT pregnant and not planning to become pregnant in the next four years?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve several visits to the clinic over a period of time. During these visits, doctors and nurses would perform various eye exams, including checking your eye pressure and your vision, and taking detailed pictures of your eyes. You would receive either the low-energy SLT treatment or the standard-energy SLT treatment, depending on which group you are assigned to. If you are in one of the low-energy groups, you might receive the treatment annually.

Throughout the study, you'll be carefully monitored to see how your eye pressure responds and if the treatment helps prevent the need for daily eye drops. The total duration of your involvement in the study would depend on which treatment group you are in and how you respond, but it could last for several years to track the long-term effects.

Potential risks and benefits

Potential benefits of joining this study include receiving careful monitoring of your eye condition and potentially benefiting from an optimized SLT treatment that might reduce your need for daily eye drops. However, like any medical procedure, SLT has potential risks, such as temporary eye discomfort, blurry vision, or a temporary increase in eye pressure. The low-energy SLT aims to reduce some of these, but they can still occur. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (29)

Harvard Eye Associates
Verified postcode
Laguna Hills, United States· Recruiting
Doheny Eye Center UCLA
Verified postcode
Pasadena, United States· Recruiting
University of California, Davis
Verified postcode
Sacramento, United States· Recruiting
University of California, San Francisco
Verified postcode
San Francisco, United States· Recruiting
Mile High Eye Institute
Verified postcode
Sheridan, United States· Recruiting
Clear Vue Laser Eye Center
City only
Lakeworth, United States· Recruiting
Northwestern Medical Group
Verified postcode
Chicago, United States· Recruiting
Chicago Arbor Eye Institute
Verified postcode
Orland Park, United States· Recruiting
Illinois Eye Center
Verified postcode
Peoria, United States· Recruiting
Wilmer Eye Institute Johns Hopkins
Verified postcode
Baltimore, United States· Recruiting
Massachusetts Eye and Ear
Verified postcode
Boston, United States· Recruiting
Ophthalmic Consultants of Boston
Verified postcode
Boston, United States· Recruiting

Common questions

What is SLT?

SLT stands for Selective Laser Trabeculoplasty. It's a gentle laser treatment for the eye that helps to reduce high eye pressure, which is a main cause of glaucoma damage.

What is glaucoma?

Glaucoma is an eye condition where the optic nerve, which connects your eye to your brain, gets damaged. This damage is often caused by high pressure inside the eye and can lead to vision loss if not treated.

Why is the study looking at different energy levels?

The study wants to see if using a lower energy for the SLT laser treatment is just as effective as the standard energy. A lower energy treatment might be gentler on the eye.

Will I have to stop my current eye drops if I join?

The study aims to see if SLT can reduce or delay the need for eye drops, but your specific medication plan will be discussed with the study doctors. Some participants might need to have not used drops recently to join.

How long will I be in the study?

The length of time you participate will depend on your assigned group and how you respond to treatment, but this kind of study often involves follow-up over several years.

How to find out more

Tony Realini, MD, MPH

hypotonywvu@gmail.com 3045986926 Official trial record

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