UK - Study for people with presbyopia (age-related near vision loss)

Presbyopia can be corrected with reading glasses or contact lenses. As it might have an impact on someone's lifestyle, surgery might be considered to correct vision.

The objective of this clinical study is to evaluate the safety and effectiveness of implantation of the corneal tissue (allografts) for improving near vision in people with presbyopia. This correction intends to eliminate the need for glasses or contact lenses.

Corneal allografts are precisely shaped micro-lenses which comprise sterile corneal tissue which has been laser processed. In this study, these tiny lenses are implanted in the cornea using a minimally invasive procedure. They are designed to change the shape of the cornea, which will adjust the point of focus of light at the back of the eye and correct vision. Such corneal allografts work much like contact lenses. They are intended to be permanent but can be removed without any residual concerns.

To participate, candidates must meet at least the following conditions:

• Glasses/contact lenses prescription between +1.75 and +3.50 D (reading add) in the non-dominant eye.
• Stable vision that has mostly remained unchanged for the past 12 months in the non-dominant eye.
• The participant must discontinue wearing contact lenses at least 3 days before the evaluation and possibly as long as 2 weeks depending on the type of contact lenses.
• Must be willing and able to return for scheduled follow-up examinations for 24 months after surgery.

The following conditions exclude candidates from participating:

• Participants who also need vision correction for long distance vision are excluded. In other words, those who had already been wearing glasses before they developed presbyopia cannot participate.
• Certain underlying eye conditions that the doctor will identify during the preoperative examination. This includes cataracts, keratoconus, severe dry eyes, certain retinal diseases, any prior eye surgery, a history of herpes infections of the eye, or glaucoma.
• Pregnant, lactating, or planning to become pregnant during the course of the study.
• Participating in any ophthalmic drug or device clinical trial during the time of this clinical investigation.

Please note that this list of conditions is not exhaustive. C-Lys selects only certain conditions and, if you meet them, we will send you to one of the participating hospitals (you can indicate your hospital of choice on the application form). All examinations conducted as part of the study will take place at the hospital under the supervision of a study physician.

The C-Lys team conducts the first pre-qualification step to verify if a candidate might be eligible to participate. Next, the C-Lys team refers the candidate to the study site.

At the study site:

• Step 1:  If you may be a candidate for the study, you will be invited for a visit at the study doctor’s office. Someone at the study doctor’s office will explain the study, including the risks and benefits and ask you to sign an informed consent document. The study doctor will then decide if you are eligible to participate in this study by performing an examination to determine the condition of your eyes.
• Step 2: If eligible for the study, the corneal allograft will be transplanted to your non-dominant eye to help your near (reading) vision. This allows for both eyes to be used for long distance vision, while the allograft sharpens near vision in the non-dominant eye. Note that near vision in only one eye is often referred to as monovision.  Our procedure is an improved version and maintains good long distance vison in the treated eye.

Your visit schedule will be as follows:

• Evaluation Day: pre-operative evaluation takes approximately 2-3 hours
• Day of surgery: surgery takes less than one hour
• After the surgery:
• After 1 Day: evaluation takes approximately 30 minutes
• Seven follow up visits each taking approximately 2-3 hours (after 7 days and after 1/3/6/12/24 months)

Each appointment will include standard ophthalmic/eye procedures and you will be asked how your eye feels. You will need to tell the study staff about any problems you might have had since your last visit.

The participating study site in the UK:

• Centre For Sight, Oxshott or East Grinstead
• Queen Victoria Hospital, East Grinstead (currently not recruiting)

Before surgery, you will be required to:

• discontinue wearing contact lenses at least 3 days before your evaluation and possibly as long as 2 weeks depending on the type of contact lenses that you wear.
• wear a contact lens in one eye (as a test or trial) to see whether you can tolerate having different vision in one eye as this is what you will have after surgery.

After surgery, your doctor will ask you to follow a medication regimen and to take some protective measures.

The corneal allograft may improve your near (reading) vision without glasses. However, this cannot be guaranteed. The corneal allograft is intended to be a permanent implant and will not be removed at the end of the study. If the procedure does not have the desired effect, the implants can be removed, and your vision returns to the way it was before surgery.

As with any clinical study or surgery, there are risks for the subject. Before you decide to take part, the study staff will explain the study and the possible risks/inconveniences. You will have the opportunity to ask questions.

The investigational product, the study visits, and the surgery are paid for by the sponsor of the clinical study.

There is no financial compensation or any reimbursement of additional costs such as transportation.