RecruitingNAINTERVENTIONAL

A Prospective, Randomized Clinical Study of Two Phakic Toric Implantable Lenses

This clinical trial is looking at two different types of special lenses that can be implanted into the eye: the EYECRYL™ Phakic Toric lens and the Visian® Toric ICL. These lenses are designed to correct short-sightedness (myopia) and a common vision problem called astigmatism, where the eye's shape causes blurry vision. The main goal is to compare how well each lens improves vision and reduces the need for glasses or contact lenses for people with moderate to severe short-sightedness. The study also wants to make sure both types of lenses are safe. These lenses are different from cataract surgery lenses because they are placed in front of your natural lens, which stays in your eye.

At a glance

Status

Recruiting

Phase

Sponsor

Biotech Healthcare Holding Gmbh

Enrolment target

172

Start

10 Oct 2021

Estimated completion

01 Feb 2027

Myopia, Moderate Myopic Astigmatism Myopia, Degenerative

What is this study about?

Imagine you have moderate to severe short-sightedness, where far-away objects look blurry, and also astigmatism, which makes everything look stretched or warped. While glasses and contact lenses are common solutions, some people might consider a more permanent option. This study is investigating two types of special implantable lenses called 'phakic toric intraocular lenses'. Think of them like very advanced contact lenses that are carefully placed inside your eye during a surgery, without removing your eye's natural lens. They're designed to help your eye focus light correctly onto the retina, giving you clearer vision without needing glasses or contact lenses as much.

The main purpose of this study is to compare two specific brands of these implantable lenses: the EYECRYL™ Phakic Toric lens and the Visian® Toric ICL. Researchers want to find out which one works best at improving your vision and correcting both your short-sightedness and astigmatism. They will also be carefully checking to see if one lens is safer than the other. By comparing these two options, doctors hope to gain more information to help future patients make informed decisions about their vision correction choices.

This research is important because it could help doctors understand which of these modern lens implants offers the best results for people living with both moderate to severe short-sightedness and astigmatism. Ultimately, findings from studies like this contribute to better and safer vision correction options for many people.

Key takeaways

This study compares two implanted lenses for short-sightedness and astigmatism.
It aims to find out which lens is more effective and safer.
You must be at least 21 with stable vision to be considered.
Your natural eye lens is not removed during this procedure.
Participation involves eye surgery and multiple follow-up visits.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you need to be at least 21 years old. Your eye doctor will check if your level of short-sightedness and astigmatism can be corrected by the special lenses being studied. It's also important that your vision has been stable over the last year, meaning your prescription hasn't changed much. If you wear contact lenses, you'll need to stop wearing them for a short time before your eye checks to make sure your eyes are in their natural state.

There are also some reasons why you might not be able to join. For example, if you have other serious health problems or eye conditions, or if you've had previous eye surgery. You also can't participate if you're taking certain medications that could affect the study's results, or if you are pregnant, planning to become pregnant, or breastfeeding. The medical team will check all these things carefully to make sure the study is safe for you.

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.

Am I 21 years old or older?
Has my glasses/contact lens prescription been stable for at least 12 months?
Do I have moderate to severe short-sightedness AND astigmatism?
Do I currently have good general health and eye health?
Am I willing and able to attend all necessary follow-up appointments?
Am I not pregnant, planning to be, or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have a series of eye examinations at different times before and after your lens implantation surgery. These visits will involve various tests to check your vision, eye health, and how well the implanted lens is working. You will receive one of the two types of lenses (EYECRYL™ Phakic Toric or Visian® Toric ICL) through a surgical procedure. Details of the surgery will be explained thoroughly beforehand. You'll need to attend all scheduled follow-up appointments after the surgery so that the doctors can monitor your progress and eye health. The total duration of your participation in the study, including all follow-up visits, will be explained by the study team.

Potential risks and benefits

Taking part in any clinical study has potential benefits and risks. You might benefit from improved vision and a reduced need for glasses or contact lenses. However, as with any surgery, there are potential risks, such as infection, discomfort, or other complications, which your doctor will discuss with you in detail. There is also no guarantee that the lens will fully correct your vision. You have the right to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (4)

Precise Vision Augentagesklinik Greven
Verified postcode
Münster, Germany· Recruiting
Precise Vision Augentagesklinik Rheine
Verified postcode
Rheine, Germany· Recruiting
Precise Vision Augentagesklinik Rheine
Verified postcode
Steinfurt, Germany· Recruiting
Netradhama Superspeciality Eye Hospital
Verified postcode
Bangalore, India· Recruiting

Common questions

What is 'short-sightedness'?

Short-sightedness, or 'myopia', means you can see objects close to you clearly, but objects far away look blurry.

What is 'astigmatism'?

Astigmatism is a common eye condition where the front surface of your eye isn't perfectly round, causing blurry or distorted vision at all distances.

Are these lenses like the ones for cataract surgery?

No, these lenses are different. They are placed in your eye without removing your natural lens, unlike cataract surgery where the cloudy natural lens is removed and replaced.

Will I still need glasses after the surgery?

The goal is to significantly reduce your need for glasses, but some people might still need them occasionally for certain tasks or if a small amount of prescription remains.

Can I choose which lens I get?

No, in this type of study, which lens you receive is determined randomly, similar to flipping a coin. This helps fairly compare the two lenses.

How to find out more

BHARGAV D JOSHI, M.Sc.

bhargav.joshi@biotechhealthcare.com 917966823000 Official trial record

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