If you have been told by your eye doctor that you have glaucoma or high eye pressure, you may be able to participate in this clinical study.
A tiny medical product called the Travoprost Intraocular Implant is being tested in an investigational study to help alleviate high eye pressure. The goal of the Travoprost Intraocular Implant is to lower your eye pressure (intraocular pressure or IOP). The Travoprost Intraocular Implant slowly releases Travoprost, the active drug in a commonly used glaucoma eyedrop. Travoprost is believed to increase the fluid flowing out of the front part of your eye.
Travoprost Intraocular Implant is tiny. This implant is made of titanium and is so small you won’t be able to feel it after the procedure is done. The Travoprost Intraocular Implant is one of the smallest medical products known to be placed in the human body.
The Travoprost Intraocular Implant procedure consists of inserting an implant through a small opening in your eye. The implant is placed in a fixed location inside the eye, gradually releasing an IOP-lowering drug with the goal of lowering eye pressure long term without the use of eye drops.
Visit #1: Screening and baseline visit
To be eligible for the Travoprost Intraocular Implant clinical study, you must meet specific study criteria. These criteria are carefully determined to include those individuals who are the best possible candidates for the study. During the screening visit and the baseline visit, your study doctor will perform a series of standard eye tests and evaluations to learn as much as possible about your specific eye condition, helping determine whether the study may be right for you. If, after the screening visit, you meet the criteria for the study you will be able to continue to the next step in the study known as the baseline visit. If you were taking glaucoma medication you will be asked to stop taking it prior to the baseline visit.
Visit #2: Surgery visit
If you pass the baseline exam, you will be scheduled to undergo your surgery. As a study participant, 100% of all patients will have their glaucoma treated. You will have a 2 in 3 chance (66%) of receiving the Travoprost Intraocular Implant. If you do not receive the Travoprost implant, a 1 in 3 chance (33%), your glaucoma will be treated with eyedrops containing Timolol, a common glaucoma medication. The decision as to whether you receive the Travoprost Intraocular Implant or Timolol drops is predetermined at random.
Visit #3: Follow-up visits
Following your study surgery, you will return to your study doctor’s office approximately 16 times over a 3-year period, which is only a few visits more than glaucoma standard care. During these visits, you will complete several questionnaires and eye examination procedures so that you and your doctor can track your progress.
Will I feel anything from the Travoprost Intraocular Implant after surgery?
The Travoprost Intraocular Implant placement is done via a small incision in your cornea. The stents are very small and are not anticipated to be felt.
Why will some patients receive the Travoprost Intraocular Implant, while others will not?
The clinical study is designed to compare the results from 3 different groups of patients: One group will receive the fast-releasing implant and drops, second group will receive the slow-releasing implant and drops, and the third group will undergo a pretend surgery, (meaning the motions of a surgery will take place in the operating room but no surgery will take place) and receive only drops. By participating in the clinical study, you will have a 100% chance of being treated with a medication, 2 in 3 chance (66%) of receiving the Travoprost Intraocular Implant and a 1 in 3 chance (33%) of receiving Timolol drops.
Will I know if I received the Travoprost Intraocular Implant after surgery?
You will not be informed if you received the Travoprost Intraocular Implant until you complete the study. This is common practice in a clinical study to prevent or minimize the chance that knowledge of receiving the investigational product will influence your responses or expectations in the study.
Can I receive the Travoprost Intraocular Implant without joining the clinical study?
The Travoprost Intraocular Implant is an investigational product and can currently only be offered through the clinical study.
Will I receive any benefit from being in the study if I do not receive the Travoprost Intraocular Implant?
You will receive Timolol drops and study follow-up examinations at no cost to you. You will also be helping to further the advancement of glaucoma treatments.
Will it cost me anything to participate in the clinical study?
If you join the clinical study, the Travoprost Intraocular Implant, study drops–including Timolol– as well as all study visits and any specific examinations associated with the study, will be provided to you at no cost.
What if I join the study and decide I do not want to participate anymore?
As with all clinical studies, your participation is completely voluntary and you may leave the study at any time. This will not affect your medical care or relationship with any of your doctors.
To see the official website of the clinical trial sponsor please visit this site:
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