We Pursue Eye Research
Current Studies
2010 Studies
Artificial Iris
Background: Some people are missing the colored part of the eye, called the iris, either because it failed to form properly before they were born, or because they were hit in the eye at some point and the iris was damaged. The iris helps regulate the amount of light entering the eye, so people who are missing all or part of their iris are extremely light sensitive and have poorer vision than normal people.
Purpose: The purpose of this multi-center study is to evaluate an artificial iris that can be implanted inside the eye to help improve vision by reducing the amount of light entering the eye. The artificial iris is available in blue, brown or green colors, so it can also help provide a more normal eye appearance.
Participation: Enrollment in the primary study is complete. We led enrollment and have had over 160 study participants at our site. The continued access study is still open to enrollment.
Impact: Lack of an iris is a relatively rare condition but can be extremely debilitating, so a device that can reduce glare and light sensitivity can make a tremendous for those who are affected.
Veriflex Lens
Background: Some young people are so extremely near-sighted that they may have difficulty fully participating in sports and other normal activities.
Purpose: The purpose of this study is to evaluate a small lens that can be placed through a small incision into the front part of the eye to provide excellent distance vision. Participants retained the natural lens in the back of their eye to allow them to focus up close as well as at a distance.
Participation: In March 2007, we enrolled the first patient in this multi-center study and hosted the training session for the other sites. Patients are being followed for 3 years.
Impact: This study could help provide a new treatment option for young adults with extreme near-sightedness.
Corneal Collagen Cross-Linking
Background: Sometimes the cornea, the clear window on the front of the eye, weakens and bulges out, causing distorted vision. This condition is called keratoconus, which means cone-shaped cornea. It typically strikes teenagers and affects people in their prime working years and is the leading cause for corneal transplants in young people. In rare cases, people may experience a similar bulging of the cornea after refractive surgery and this is called ectasia.
Purpose: This study is being conducted to evaluate an investigational treatment known as corneal collagen cross-linking that may help strengthen and stabilize the cornea. Keratoconus patients and post-refractive ectasia patients are currently being enrolled.
Participation: We are enrolling up to 200 patients in this study.
Impact: If proven successful, this treatment would be the first to actually treat the underlying weakness in eyes with keratoconus or ectasia, and it could help these patients achieve better vision and avoid the need for a corneal transplant.
Riboflavin/UV light treatment for eye infections
Background: The eye can become infected with a variety of organisms, and some can take months to eradicate. People who wear contact lenses have higher risk of developing corneal infections.
Purpose: The purpose of this study is to evaluate whether treatment with riboflavin (vitamin B) and a specific wavelength of ultraviolet light for different lengths of time can help clear an eye infection more quickly than use of antibiotic eye drops alone.
Participation: We are enrolling up to 200 patients in this investigational study.
Impact: This treatment could provide a new way to help clear up eye infections before they cause permanent scarring and vision loss.
LASIK Study
Background: Millions of Americans have had laser refractive surgery (LASIK) to correct near-sightedness or far-sightedness. A temporary side effect is loss of sensation on the front part of the eye. This reduces the tendency to blink and produce tears, which can cause the eyes to feel drier than usual with some temporary distortion of vision.
Purpose: The purpose of this investigational study is to evaluate whether a new type of eye drop can help restore corneal sensation more quickly than usual after LASIK.
Participation: We plan to enroll up to 80 participants and follow them for a 6-month period.
Impact: This new treatment may help restore corneal sensation and crisp vision more rapidly after LASIK.
Light-adjustable Lens for Cataract Patients
Background: As people age the natural lens in the back of eye becomes cloudy; this is called a “cataract”. The cataract can be removed and replaced with a small plastic lens, called an IOL.
Purpose: The purpose of this multi-center research study is to evaluate an investigational new IOL that can be adjusted to fine-tune someone’s vision after the lens is inside the eye.
Participation: Enrollment in the current phase of study is complete. Patients are being followed for 3 years. A follow up phase may open to enrollment in 2010.
Impact: This lens could potentially provide the people with truly customized vision after cataract surgery.
Genetics of Fuchs’ Dystrophy
Background: The cornea is the clear window that covers the center of the eye. Unfortunately, as some people get older, their cornea becomes cloudy because of a condition known as Fuchs’ dystrophy. We don’t know what causes this condition but it seems to run in families, so we think it may have a genetic basis.
Purpose: The purpose of this study, sponsored by the National Eye Institute, is to identify the genes involved in Fuchs’ dystrophy so that we can figure out why this condition occurs and develop ways to prevent its progression.
Participation: We have led enrollment in this study with over 70 families participating at our site.
Impact: Patients with Fuchs’ dystrophy have been very excited to help us find out what causes this condition and hopefully find a cure before their children and grandchildren become affected by it!
Cornea Donor Study
Background: Surgeons have generally assumed that it is best to give a cornea transplant recipient a donor cornea that is of similar age or younger. However, the supply of young organ donors is limited.
Purpose: The purpose of this study is to find out whether a cornea transplant will last just as long if the donor was older than 65 years, compared with using younger donor tissue.
Participation: This multi-center study, sponsored by the National Institute of Health (NIH), began in 2000. We are following the patients for 10 years.
Impact: The overall graft health and survival rate was similar for the younger and older donor groups at 5 years. This has increased the use of older donor corneas, which has helped expand the limited supply of corneal tissue.
Small incision transplants (DSEK)
Background: A traditional full thickness cornea transplant (known as penetrating keratoplasty, or PK) replaces the entire central part of the cornea with donor tissue that is sutured into place. Unfortunately, this technique permanently weakens the eye and increases the risk of losing the eye from minor trauma, such as a fall. The recovery period can take a year or longer and the patient often experiences significant and unpredictable changes in their glasses prescription.
Purpose: The purpose of this study is to evaluate a new transplant technique (known as DSEK or DSAEK) in which healthy donor tissue is placed behind the patient’s own cornea through a small incision.
Participation: We are following over 1300 patients who have had this procedure done since December 2003.
Impact: We have shown that this procedure is safer and provides faster visual recovery than PK. Furthermore, in patients who have had their grafts 5 years or longer, the long term graft survival rate compares favorably with PK. This procedure is now being adopted around the world. Between one third and one half of all transplant patients qualify for this procedure and it now accounts for over one third of the transplants being performed in the USA.
Ultra-thin Transplant (DMEK)
Background: The cornea or “window” of the eye is about the thickness of a credit card. Although the cell layer lining the back of the cornea is less than 10% of the corneal thickness, problems with that single cell layer can make the entire cornea become cloudy.
Purpose: The purpose of this study is to evaluate a new transplant technique (DMEK) that removes the single defective cell layer and replaces it with a single healthy cell layer from a donor cornea.
Participation: We are evaluating over 80 patients who have had this new single cell layer transplant since February 2008.
Impact: We have found that this technique provides extremely fast visual recovery and allows significantly more patients to recover 20/20 vision than earlier techniques. The single cell layer from the donor cornea is very fragile and can sometimes tear so we are working on refinements to prevent loss of precious donor tissue.
Hybrid ultra-thin transplant (DMAEK)
Background: We have found that an ultra-thin, single cell layer transplant can provide the best possible vision for people with Fuchs’ dystrophy or endothelial dysfunction, but a single cell layer donor graft is fragile and can sometimes tear as it is being prepared.
Purpose: The purpose of this study is to evaluate a new method for isolating a single cell layer from the donor cornea while leaving a rim of supporting tissue.
Participation: We are evaluating over 50 patients who have had this hybrid transplant since November 2008.
Impact: DMAEK provides superb visual results for the patient, like DMEK, plus it facilitates the surgical procedure, which may result in faster adoption by surgeons.
Culturing Cell Sheets for Transplants
Background: Donor corneas are in short supply around the world so many people who could benefit from a transplant are not able to have one. While donor tissue is screened there is always the risk of disease transmission with donated tissue. Likewise, problems can occur with healing and good visual results may not always happen after a transplant. Therefore, finding alternatives to transplants that allow people to maintain their own corneas are desirable.
Purpose: The purpose of this study is to develop methods to multiply precious cells from a single donor cornea and grow them into sheets for transplantation to restore sight.
Participation: We are collaborating on this project with adult stem cell experts at the Wells Center for Pediatric Research at Indiana University.
Impact: This study could help alleviate the chronic worldwide shortage of suitable donor corneas and restore sight to countless people.
