Active not recruitingNAINTERVENTIONAL

Treatment of Vision Disturbances Due to Corneal Irregularities by Trans-epithelial Optical Phototherapeutic Keratectomy (TE-oPTK)

This study aims to make laser eye surgery called Trans-epithelial Phototherapeutic Keratectomy (TE-PTK) more precise. TE-PTK is used to treat vision problems like glare or double vision caused by an uneven front surface of the eye (cornea). The software, called EpiMaster, helps doctors predict how a patient's vision, specifically their short-sightedness, long-sightedness, or astigmatism, might change after the TE-PTK procedure. Currently, these vision changes can be a bit unpredictable. By improving these predictions, the study hopes to make the treatment more effective and reliable for people whose vision is affected by these specific corneal irregularities. Researchers will compare the software's predictions to actual patient outcomes to see how well it works.

At a glance

Status

Active not recruiting

Phase

Sponsor

London Vision Clinic

Enrolment target

Start

01 Aug 2019

Estimated completion

01 Nov 2028

Corneal Astigmatism

What is this study about?

When you have laser eye surgery, sometimes the front surface of your eye, called the cornea, can become a bit uneven. This can lead to annoying vision problems such as seeing halos around lights, glare, double vision, or finding it hard to see clearly in low contrast. There are different types of laser treatments to fix these irregularities.

One common treatment, called "topography-guided ablation," uses a laser to reshape the cornea based on a detailed map of its surface. However, this isn't always the best solution for all types of unevenness. This is because the outer layer of the cornea (the epithelium) can cleverly mask some of these deeper irregularities. Think of it like a thin blanket covering bumps and dips – the surface might look smoother than what’s underneath.

For these specific cases, another treatment called Trans-epithelial Phototherapeutic Keratectomy (TE-PTK) is often preferred. This treatment works by removing tissue from both the outer layer and the underlying structural layer of the cornea, aiming to smooth out those deeper bumps and dips. The challenge with TE-PTK is that the changes to your vision, like becoming more short-sighted or long-sighted, can be a bit unpredictable. This is where our new software, EpiMaster, comes in. We’re hoping it will help doctors accurately predict these vision changes, making the TE-PTK procedure much more precise and effective.

Key takeaways

This study evaluates new software to improve laser eye surgery for irregular corneas.
It aims to make TE-PTK surgery more predictable for vision changes.
Participants have vision problems due to an uneven eye surface.
The software predicts how short-sightedness, long-sightedness, or astigmatism might change.
The goal is to provide better, more precise treatment for certain vision issues.

Who may be eligible?

To be considered for this study, you would typically need to be at least 21 years old and have an uneven corneal surface (irregular astigmatism) that is causing vision problems. Importantly, your eye doctor would need to determine that the TE-PTK treatment is a better option for you than other available laser eye surgeries.

You would also need to be generally healthy and suitable for laser eye surgery, meaning you don't have certain conditions like autoimmune diseases, uncontrolled diabetes, or specific eye diseases such as cataracts or glaucoma. Your cornea also needs to be thick enough for the surgery, and your vision prescription needs to be stable.

Finally, if you wear contact lenses, you'd need to stop wearing them for a certain period before your initial eye measurements. You would also need to be able to understand the study information, agree to take part, and be willing to attend all scheduled follow-up appointments.

Quick self-check

Are you 21 years of age or older?
Do you have vision problems caused by an uneven front surface of your eye?
Are you in generally good health and suitable for laser eye surgery?
Are you willing and able to attend all study appointments?
Do you not have diabetes, autoimmune diseases, or specific eye conditions like glaucoma or cataracts?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, it would involve a series of appointments where your eyes will be carefully examined. This includes detailed measurements of your eye's surface and your vision. You will undergo the TE-PTK laser eye surgery procedure. After the surgery, you will have follow-up visits to check how your eyes are healing and how your vision has changed. Researchers will compare your actual vision changes to what the EpiMaster software predicted. You will need to commit to attending all required follow-up appointments and examinations for the full duration of the study.

Potential risks and benefits

Participating in this study means you may benefit from a more accurately planned laser eye surgery that aims to improve your specific vision problems. However, like any medical procedure, there are potential risks associated with laser eye surgery, including infection, glare, halos, or the need for further treatment. Your doctor will discuss all potential risks with you. You have the right to withdraw from the study at any time without giving a reason, and this will not affect your future medical care.

Locations (1)

London Vision Clinic
London, United Kingdom

Common questions

What is astigmatism?

Astigmatism is a common vision condition caused by an irregularly shaped cornea (the front surface of your eye) or lens inside the eye. It blurs vision at all distances.

What is TE-PTK?

TE-PTK stands for Trans-epithelial Phototherapeutic Keratectomy. It's a type of laser eye surgery used to smooth out irregularities on the surface of your cornea to improve vision.

What is the EpiMaster software?

EpiMaster is a new computer program being tested in this study. It's designed to help doctors predict how a patient's vision will change after TE-PTK surgery, making the treatment more precise.

Will I need to stop wearing my contact lenses?

Yes, if you wear contact lenses, you will need to stop wearing them for a specific period before your initial eye measurements for the study. Your doctor will advise you on the exact timeframe.

What complications can occur after laser eye surgery?

Sometimes, after laser eye surgery, the front of the eye can become uneven, leading to issues like halos, glare, double vision, or reduced clarity. This study aims to improve treatment for such complications.