BridgeMD
New treatment option for Keratoconus
Official title Investigator Initiated, Prospective Study of Xenia Corneal Lenticule
ClinicalTrials.gov ID: NCT04741230
What this study is testing
- What it's testing
- Cornea ectatic conditions such as keratoconus and post-LASIK (Laser In situ Keratomileusis) ectasia are disorders of the eye that are notorious for its uncontrolled progression over time, leading to loss of vision. There are valuable treatment options for controlling disease progression in mild to moderate stages of such disease.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 79
You may be able to join if
- Diagnosis of severe keratoconus in patients who would prefer to avoid corneal transplant surgery / penetrating keratoplasty OR
- Diagnosis of severe post-LASIK Ectasia in patients who would prefer to avoid corneal transplant surgery / penetrating keratoplasty
- In terms of general health, patients must be free of diagnosed terminal illnesses (life expectancy of greater than or equal to 2 years).
- Patients must be aged 18 years or over and less than 80 years old
- Patients' contact lenses must have been removed at least one-week prior to surgery for soft lenses and two weeks prior to surgery for hard lenses
You likely can't join if
- History or presence of any ocular pathologies that may interfere with the planned surgical treatment, including corneal epithelial problems
- Previous corneal transplantation or corneal implant in the designated eye
- Cataract with anticipated surgical intervention (IOL implantation) within 2 years
- Active inflammation and/or infection of the eye or the eye lid
- Patients with Intra Ocular Pressure (IOP) \ 21 mmHg
- Professionally diagnosed and currently treated autoimmune diseases
See the full eligibility criteria
- Diagnosis of severe keratoconus in patients who would prefer to avoid corneal transplant surgery / penetrating keratoplasty OR
- Diagnosis of severe post-LASIK Ectasia in patients who would prefer to avoid corneal transplant surgery / penetrating keratoplasty
- In terms of general health, patients must be free of diagnosed terminal illnesses (life expectancy of greater than or equal to 2 years).
- Patients must be aged 18 years or over and less than 80 years old
- Patients' contact lenses must have been removed at least one-week prior to surgery for soft lenses and two weeks prior to surgery for hard lenses
- Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed
- Patient must be able and willing to complete all study visits and comply with the study-specific requirements
- History or presence of any ocular pathologies that may interfere with the planned surgical treatment, including corneal epithelial problems
- Previous corneal transplantation or corneal implant in the designated eye
- Cataract with anticipated surgical intervention (IOL implantation) within 2 years
- Active inflammation and/or infection of the eye or the eye lid
- Patients with Intra Ocular Pressure (IOP) \ 21 mmHg
- Professionally diagnosed and currently treated autoimmune diseases
- Current strong symptoms of any allergy
- History of major organ transplantation and/or current continuing immunosuppressive treatment
- History of blood transfusion within the last 12 months
- Subject who is currently participating or has participated in another investigational clinical study within the past 60 days Pregnancy and lactation
The study team makes the final eligibility decision.
Where it's taking place
- Wolverhampton, West Midlands, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 79 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wolverhampton, West Midlands, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.