Clinical evaluation of prototype scleral contact lenses
As we get older, our eyes naturally lose the ability to switch focus smoothly between distant and close-up objects. This common change is called presbyopia. Many people also have astigmatism, where the front of the eye is shaped more like a rugby ball than a football, causing blurred vision. This early-stage clinical trial tests a prototype scleral contact lens. Unlike ordinary contact lenses that sit on the clear window of the eye (the cornea), scleral lenses are slightly larger and rest on the white part of the eye (the sclera). Researchers want to find out whether a newly designed optical feature helps people see clearly and comfortably at different distances. Participants try both the test lenses and standard lenses for 30 minutes each over two visits to compare vision, comfort, and satisfaction.
At a glance
What is this study about?
As we reach middle age, the natural lens inside the eye becomes less flexible. This makes everyday tasks like reading small print, using a mobile phone, or looking at a menu much harder. At the same time, many people have astigmatism, meaning the eye's surface is slightly uneven, which blurs vision at any distance. Wearing ordinary contact lenses that fix both issues at once can sometimes be tricky or uncomfortable.
Scleral lenses offer an alternative approach. They are larger, firm lenses that vault smoothly over the sensitive front surface of the eye and rest gently on the white part, known as the sclera. Because a thin cushion of fluid sits between the lens and the eye, they can provide very crisp vision and good comfort. In this trial, scientists have developed a prototype scleral lens with a brand-new optical design aimed at improving both near and distance sight.
This study is an early 'proof-of-concept' test. Its main goal is to check that the new design works as intended and does not cause unwanted visual side effects. By comparing the new prototype directly against an existing, approved scleral lens, the research team hopes to learn whether this technology could lead to better everyday contact lens options in the future.
Key takeaways
- Tests a new optical design in scleral contact lenses for adults aged 40 and over.
- Aims to help people who struggle with both reading vision (presbyopia) and astigmatism.
- Involves two short clinic visits, wearing study lenses for 30 minutes each time.
- You do not take the lenses home, and no medications are required.
- Participation is entirely voluntary, and you can withdraw at any point.
Who may be eligible?
You may be able to take part if you are aged 40 or older, currently wear contact lenses, and have both age-related reading difficulty (presbyopia) and mild astigmatism. You must have reasonably good vision in both eyes when wearing your normal glasses or lenses.
You cannot take part if you have active eye infections, severe dry eyes, or reduced feeling in your eyes. People who have had eye surgery, have an irregularly shaped cornea, or have only one functioning eye are also excluded.
Additionally, the study is not suitable for anyone who is pregnant or breastfeeding, has certain long-term health conditions that affect the eyes, or takes medications that make wearing contact lenses unsafe.
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.
- I am aged 40 or older.
- I currently wear contact lenses.
- I need help with both close-up reading and general distance vision.
- I have astigmatism in my current glasses or contact lens prescription.
- I do not have active eye infections, severe dry eye, or previous eye surgery.
- I am not pregnant or breastfeeding.
What does participation involve?
Taking part involves two separate visits to an eye clinic in London. At each visit, you will be fitted with a pair of scleral contact lenses. In one session, you will wear the new prototype lenses, and in the other, you will wear standard control lenses. The order in which you try them is decided randomly.
You will wear the lenses in the clinic for about 30 minutes during each visit. You do not take the lenses home. After the 30-minute wearing period, the clinic team will check how well you can see and ask you questions about how comfortable the lenses felt and how satisfied you were with your vision. There are no ongoing medications or long-term follow-up visits required.
Potential risks and benefits
Locations (1)
- Ocular Technology Group InternationalUnverifiedLONDON, England
Common questions
What makes scleral lenses different from ordinary soft lenses?
Scleral lenses are slightly larger and rest on the white of the eye rather than directly on the sensitive cornea. They vault over the eye's front surface, held by a gentle layer of fluid.
Do I get to take the contact lenses home?
No. This is an in-clinic test only. You will wear each pair for around 30 minutes while being checked by the study team, and then they are removed.
Will taking part hurt?
Fitting scleral lenses may feel unusual if you have only worn soft lenses before, but it should not be painful. The clinic team will guide you through the process carefully.
How long will the entire study take for me?
You will attend two separate clinic appointments, each lasting long enough to fit the lenses, wear them for 30 minutes, and complete the vision checks.
Does this trial replace my regular optician check-ups?
No. This study only evaluates a specific research lens. You should continue to see your regular optometrist or eye doctor for routine eye examinations.
How to find out more
Deborah Moore
Always speak to your GP or specialist before deciding to take part in a study.
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