Clinical Trials and Clinical Research
To learn more about clinical trials and clinical research on treatments for eye disease please call or email the contact for the specific study below.
For a longer list of studies needing volunteers throughout the U-M Health System, please go to UMClinicalStudies.
- Cornea and External Disease
- Oculoplastic and Orbital Oncology
- Pediatric Ophthalmology
- Thyroid Eye Disease
- Dry Eye Assessment and Management (DREAM) Study
IRB Number: HUM00086107
- The DREAM study will evaluate the effectiveness and safety of using supplements of omega-3 fatty acids to treat the symptoms of moderate to severe dry eye disease. Currently, these over-the-counter nutritional supplements are used to treat high levels of fat in the blood. Kellogg is one of several national eye centers participating in this study, which is funded by the National Eye Institute, a branch of the National Institutes of Health.
- 18 or older
- Have had dry eye symptoms for at least six (6) months
- Be able to swallow five (5) large soft gel capsules daily
- Be available for one (1) year of follow-up
- For some participants who qualify, be available for a second year of follow‐up
Principal Investigator: Roni Shtein, M.D., M.S.
- Long-term outcomes after laser in situ keratomileusis (LASIK): mechanical microkeratome vs femtosecond laser
IRB Number: HUM00049051
- To assess long term outcomes of patients who underwent laser in situ keratomileusis (LASIK) with microkeratome and femtosecond laser flaps. Subjects can take part in this study if they have had LASIK surgery for correction of myopia or myopic astigmatism at the Kellogg Eye Center with either the microkeratome or femtosecond laser for LASIK flap creation in the last 5 to 10 years.
Study Coordinator: Munira Hussain, M.S., CCRP, email@example.com
Principal Investigator: Roni Shtein, M.D., M.S.
- The Process of Development of Dry Eyes
IRB Number: HUM00013091
- We will evaluate female patients with dry, gritty, itchy and tired eye symptoms, also known as dry eye, without any apparent cause. Patients will be tested for abnormalities in sensory processing to investigate possible relationships between dry eye symptoms and fibromyalgia in an effort to better understand and treat both of these conditions. This study will consist of two separate visits, one at the Kellogg Eye Center and the other at Dominos Farms. At Kellogg, we will evaluate patients with dry eye symptoms. The Domino's Farm visit, patients will be tested for abnormalities in sensory processing to investigate possible relationships between dry eye symptoms and fibromyalgia.
- Age range from 18 - 69 years
- This study is seeking Female Healthy Subjects
- Fibromyalgia Controls ages 20 through 49 and ages 60 through 69
- Healthy Controls ages 30 through 70
- You may not participate if:
- you are taking oral allergy medication
- you are taking oral anticholinergic medication
- you are using daily inhaler for asthma
- you have had prior eye surgery
Principal Investigator: Roni Shtein, M.D.
- Glaucoma and Biomarkers
IRB Number: HUM00052276
- Glaucoma is a major cause of blindness. The inability to predict a patient’s eye pressure response to medications is a critical barrier for the clinician to consistently provide highly effective eye pressure-based treatments. Current trial-and error approaches to glaucoma management are inefficient and have not addressed this barrier as there are no predictive factors for drug response. Our research project will address this critical barrier by focusing on physiological factors that predict eye pressure response to drugs. The purpose of our study is to improve glaucoma outcomes by identifying biomarkers and environmental factors that profile a patient at risk for glaucoma by age-of-onset, rate of disease progression, “poor response” to treatment, and large eye pressure fluctuation.
- Age Range: From 40 to 100 years
- Gender: Both Female and Male
- Ethnicity: All
- Race: All
- Smoking: Both Smoking and No-Smoking
- This study is seeking: Healthy Subjects
- Some compensation is available
Study Contact: Diana Burnett, M.S., (734) 936-2929, firstname.lastname@example.org
Principal Investigator: Sayoko E. Moroi, M.D., Ph.D.
Expected Recruitment End Date: 01/31/2016
- VISmodegib for ORBital and periocular basal cell carcinoma (VISORB)
IRB Number: HUM00082579
Basal cell carcinoma (BCCA) is the most common human cancer, affecting approximately 750,000 Americans per year. BCCAs are generally treated by local excision, which in many cases is associated with scarring and potential disfigurement. Vismodegib is a medical treatment for BCCA, taken orally, and has been recently approved by the Food and Drug Administration (FDA).
The purpose of this study is to follow the treatment course for orbital BCCA with vismodegib and record medical information in order to determine whether treatment with vismodegib improves the chance of maintaining functional vision and/or functional tear drainage system.Eligibility
Your doctor has determined that you have orbital BCCA or BCCA around the eye that threatens the eye and/or the tear drainage system, and your doctor recommends treatment with vismodegib.
Additional eligibility criteria:
- You are 18 years or older
- Ability or willingness to swallow capsules
- Ability or willingness to comply with study procedures and protocol
- No pregnant, lactating or breast feeding women
- No women of childbearing potential.
- No uncontrolled medical illnesses
- An Open-Label, Pharmacokinetic and Safety Study of Travoprost Ophthalmic Solution, 0.004% in
Pediatric Glaucoma or Ocular Hypertension Patients
IRB Number: HUM00070527
Glaucoma is an eye condition in which damage to the optic nerve results in gradual loss of sight. Ocular hypertension is an eye condition in which the pressure in the eye is abnormally high and if not treated may develop into glaucoma.
The purpose of this research study is to obtain information on the safety of the study medication Travoprost Ophthalmic Solution, 0.004% in pediatric glaucoma or ocular hypertension patients and to evaluate the amount of study medicine after the study medication is used once daily for at least 7 days.
Travoprost Ophthalmic Solution, 0.004% is a new formulation that has not been approved to treat glaucoma and ocular hypertension in children less than 18 years of age, and therefore its use in this study is investigational.Eligibility
- Study participants who are 2 months to less than 18 years of age with a diagnosis of glaucoma or ocular hypertension in at least 1 eye are invited to participate in this study
- Be willing to use Travoprost Ophthalmic Solution, 0.004% for 7days
- Be willing to have blood drawn on the last study visit
- Be able and willing to comply with study visits and procedures for approximately 7 days
Principal Investigator: Monte Del Monte, M.D.
- Clinical evaluation of patients with X-linked Retinoschisis (XLRS)
X-linked Retinoschisis (XLRS) is caused by mutations in a gene called Retinoschisin (RS1). The RS1 gene makes a protein that is important for the health of the retina. The condition impairs normal vision and typically causes loss of central vision. Many patients with XLRS develop a condition called
maculoschisis. With maculoschisis, fluid appears in the macula and can cause the retina to swell.
Mauloschisis is usually treated with a class of drugs called carbonic anhydrase inhibitors (CAIs). We are doing a study to understand the vision is affected in people with XLRS. This information will be important in the development in new treatment trials in the future.
There are 2 types of participants needed for this study:
- The main study will follow subjects who do not have the mauloschisis
- The sub-study is for subjects who have mauloschisis who need to be treated with CAIs.
- Male Patients
- Ages 7 years old and older
Clinical diagnosis of XLRS and genetic testing done to identify RS1 gene mutations (genetic testing can be done as a part of study)
- Participant may not have:
Other eye diseases that might affect the results (e.g. history of retinal detachment, glaucoma, cataracts that prohibit imaging, or any other eye pathology that in the opinion of the investigator would preclude enrollment)
- Lindsay Godsey, (734) 936-9798, email@example.com
- Principal Investigator: John R. Heckenlively, M.D. and K. Thiran Jayasundera, M.D.
- Normative Optical Coherence Tomography (OCT) Database
IRB Number: HUM00072124
We are creating an image database of healthy human retinas by using optical coherence tomography (OCT), which is a non-invasive imaging technique. We are recruiting volunteers with healthy eyes to create a database of retinal images. We will take pictures of the back part of your eye(s) using a special technique called optical coherence tomography (OCT). To take the pictures, you sit in front of the OCT instrument with your head in a chinrest while lights are shined into your eye(s). We will also briefly review your medical records to ensure that you do not have any diseases that can affect your eyes and that you are not taking any medications that can affect your eyes. Your study visit would last roughly 15 minutes. The eye test that you will receive is free.
- Men and women ages 18 years and older
- Participants must not:
- Have glaucoma, severe cataract, macular degeneration, or other eye diseases that impair vision
- Have a neurologic or general medical condition that impairs vision such as uncontrolled high blood pressure, diabetes, stroke, multiple sclerosis, or HIV/AIDS
- Be taking a medication that affects your eyes (like Plaquenil)
- Have Parkinson’s disease or Alzheimer’s disease
- Relating Retinal Structural and Functional Parameters to Visual Acuity in Eyes Undergoing Treatment for Diabetic Macular Edema
IRB Number: HUM00064483
- This study is attempting to better understand why some people diagnosed with diabetic macular edema (DME) have improved vision when they are treated, while others do not improve. The study requires about 5 visits to the Kellogg Eye Center for approximately one year.
- Patients, both male and female, with macular edema involving the center of the retina
- Ages 18 years old and older
- Have a visual acuity between 20/40 and 20/400
- Participants must not:
- Have glaucoma, severe cataract, or other retinal or neurologic diseases that impair vision
- Have received treatment for diabetic macular edema or had eye surgery in the last 4 months
- Have uncontrolled high blood pressure
- Be pregnant or nursing
- Have a history of small bowel surgery
- Have liver disease
- Be extremely near-sighted
- Pamela Titus, COT, (734) 936-0138, firstname.lastname@example.org
- Lindsay Godsey, M.S. (734) 936-9798, email@example.com
- VPA Trial for Retinitis Pigmentosa
IRB Number: HUM00061649
- Retinitis Pigmentosa (RP) is a severe disease of the retina characterized initially by night blindness with progression to tunnel vision and eventual loss of central vision and total blindness. Targeted therapies for RP are complicated by the identification of more than 30 genes identifed being responsible for dominant and recessive forms of the disease and many more linked to RP but not identified. Currently there is no FDA approved therapy to substantially alter or reverse the progression of RP, and the development of new treatments is an important goal.
Valproic acid has a number of properties that make it a good candidate for treating autosomal dominant RP.
This study is designed as a multi-site, interventional, prospective, randomized, placebo-controlled, masked study of 90 participants to evaluate the efficacy of oral VPA to both slow the progression of visual function loss and or to restore visual function in patients with RP and to collect safety and tolerability information. The study population will be comprised of male and female patients who have been diagnosed with autosomal dominant retinitis pimentosa (adRP) and who meet inclusion/exclusion criteria outlined in sections 4.3 and 4.4 of the protocol.
- Patients with Retinitis Pigmentosa
Principal Investigator: John R. Heckenlively, M.D., K. Thiran Jayasundera, M.D.
- MacTel The Macular Telangiectasia Project
IRB Number: 2005-0496
- Macular Telangiectasia is a disorder of the blood vessels which supply the macula. The macula is the part of the retina that is responsible for the central vision. The fovea, in the center of the macula, has no blood vessels at all because they would interfere with the central vision. MacTel refers to a condition of the blood vessels around the fovea which become dilated and incompetent, like varicose veins but on a much smaller scale. People do not usually go completely blind from this condition, but it commonly causes loss or distortion of the central vision.
At the present time there is no treatment for this disease. The MacTel Project is a Natural History Study following patients affected with Macular Telangiectasia. Genetic samples of affected individuals and their families are collected to establish whether there is a genetic component of the disease.
Study Coordinator: Pamela Titus, COT, (734) 936-0138, firstname.lastname@example.org
Principal Investigator: Grant M. Comer, M.D.
- Safety and effectiveness of an investigational drug called RV 001 in the treatment of Thyroid Eye Disease
IRB Number: HUM00073174
- The purpose of this study is to obtain information on the safety and effectiveness of an investigational drug called RV 001 in the treatment of Thyroid Eye Disease. The study will compare RV 001 to a placebo ('dummy' treatment).
The study is approximately 18 months long with up to 19 clinic visits. All patients will receive the study treatment as an infusion into a vein approximately 8 times in a 6 month period followed by 5 follow up clinic visits in the remaining 12 months. Blood samples will be obtained for testing.
- Currently have Thyroid Eye Disease
- Patients, both male and female
- All ages welcome