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 Trials

Collagen Crosslinking Study
IRB Number: HUM00069402
Do you suffer from keratoconus or corneal ectasia? Cornea faculty at the Kellogg Eye Center are conducting a clinical research trial to study an investigational treatment to stop or slow the progression of keratoconus and corneal ectasia.

Eligibility
  • 12 years of age or older
  • Diagnosed with keratoconus or with corneal ectasia after you received refractive surgery (e.g., LASIK, PRK)
  • Able to come in for at least 8 office visits over a 12 month period
Study Coordinator: Munira Hussain, hussain@med.umich.edu, 734-647-8397
Principal Investigator: Shahzad Mian, M.D.
Recruitment: Open
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, hussain@med.umich.edu
Principal Investigator: Roni Shtein, M.D.
Recruitment: Open
In Vivo Corneal Confocal Microscopy for Non-invasive Assessment of Diabetic Peripheral Neuropathy
IRB Number: HUM00042377
Peripheral neuropathy is caused by nerve damage. It can result from such problems as traumatic injuries, infections, metabolic problems and exposure to toxins. One of the most common causes is diabetes. Peripheral neuropathy often causes numbness and pain in your hands and feet.

The goal of this study is to develop a non-invasive diagnostic protocol as a way to evaluate diabetic peripheral neuropathy.

Eligibility
  • Age range from 18-70 years
  • Both female and male
  • Medication restriction: Medicated eye drops in the past month
  • This study is seeking patients with diabetes
  • You may not participate if you have had:
    • Laser eye surgery
    • Spinal Stenosis
    • Back surgery
    • Stroke
    • Cancer
    • Parkinson’s
    • Multiple Sclerosis
    • Corneal disease
Study Coordinator: Munira Hussain, hussain@med.umich.edu
Principal Investigator: Roni Shtein, M.D.
Recruitment: Closed
Diagnostic Imaging for Intraoperative Floppy Iris Syndrome
IRB Number: HUM00039333
Some men who have a history of use of tamsulosin (Flomax) are at risk for a condition called Intraoperative Floppy Iris Syndrome that can develop during otherwise routine cataract surgery. It is not fully understood why this condition develops or who is at risk for developing it. We hope that the results of this study will provide a better understanding of how Intraoperative Floppy Iris Syndrome develops and give us a non-surgical way of figuring out who might develop this problem during surgery.

Eligibility
  • Age range from 18-99 years
  • Medication restriction: No glaucoma meds
  • This study is seeking male patients who have a history of taking tamsulosin (Flomax)
  • You may not participant if you have:
    • Diabetes
    • Glaucoma
    • Prior eye surgery or trauma
    • Black or dark brown eyes
Study Coordinator: Munira Hussain, hussain@med.umich.edu
Principal Investigator: Roni Shtein, M.D.
Recruitment: Closed
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.

Eligibility:
  • 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
Study Coordinator: Munira Hussain, hussain@med.umich.edu
Principal Investigator: Roni Shtein, M.D.
Recruitment: Open
Cornea Transplant Study
IRB Number: HUM00006281
This study will evaluate blood vessels in cornea transplants to see if we can predict transplant rejection and/or failure.

Blood vessels in the cornea are known to be a risk factor for corneal transplant rejection and failure. We will examine patients carefully with high powered microscopes to look for and measure blood vessels in their cornea transplants. Patients will be followed at their normal post-operative visits - this study will not require additional visits.

Eligibility:
  • Age Range: From 18 To 100 years
  • Gender:Both Female and Male
  • Smoking: Both Smoking and No-Smoking
  • Medication: No Restriction
  • This study is seeking: Patient with Specific Condition
  • Handedness: Either
Study Coordinator: Munira Hussain, hussain@med.umich.edu
Principal Investigator: Roni Shtein, M.D.
Recruitment: Closed
Corneal Preservation Time Study (CPTS)
IRB Number: HUM0005928
The CPTS is a nationwide study sponsored by the National Eye Institute. CPTS seeks to examine corneal preservation time and transplant success and to determine whether donor corneas preserved beyond seven days, within the FDA guidelines, may help increase the cornea supply available for transplants in the U.S.

Eligibility:
  • Age range: 30-85 years
  • Both female and male
  • Diagnosis of Fuchs’ Dystrophy or corneal swelling following cataract surgery
  • Patients in need of a corneal transplant (DSAEK)
Study Contact: Munira Hussain, hussain@med.umich.edu
Principal Investigator: Alan Sugar, M.D.
Recruitment: Closed

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Glaucoma Trials

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.

Eligibility
  • 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
Location of Study Visits: Ann Arbor, MI

Study Contact: Diana Burnett, M.S., (734) 936-2929, burnettd@med.umich.edu
Principal Investigator: Sayoko E. Moroi, M.D., Ph.D.
Recruitment: Open
Expected Recruitment End Date: 01/31/2016

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Pediatric Ophthalmology Trials

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
Study Contact: Karen King, (734)936-8681, kaking@med.umich.edu
Principal Investigator: Monte Del Monte, M.D.
Recruitment: Closed

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Retina Trials

Clinical evaluation of patients with X-linked Retinoschisis (XLRS)
IRB Number:HUM00078039
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.
Eligibility
  • 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)
Study Contact:
  • Lindsay Godsey, (734)936-9798, godseyli@med.umich.edu
  • Principal Investigator: John R. Heckenlively, M.D. and K. Thiran Jayasundera, M.D.

Recruitment: Open

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.

Eligibility:

  • 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
Study Contact: Recruitment: Open
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.

Eligibility:
  • 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
Study Contacts: Principal Investigator: Grant Comer, M.D.
Recruitment: Open
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.

Eligibility
  • Patients with Retinitis Pigmentosa
Study Coordinator: Lindsay Godsey, 734-936-9798,  godseyli@med.umich.edu
Principal Investigator: John R. Heckenlively, M.D., K. Thiran Jayasundera, M.D.
Recruitment: Open
Mechanisms of Visual Function Loss in Proliferative Diabetic Retinopathy
IRB Number: HUM00060596
The purpose of this study is to characterize deficits in retinal structure and function among patients with proliferative diabetic retinopathy and in subjects with healthy eyes (controls).   A number of tests will be performed on participants, such as visual field measurements, dark adaptation, eye photographs, color vision assessment, and others. These tests pose minimal risk and none of the eye tests are invasive.  A small amount of blood may be obtained from participants to measure hemoglobin A1C levels. Compensation for participation is available.

For control subjects, this study will require one visit to the Kellogg Eye Center. Patients with proliferative diabetic retinopathy will have up to 3 visits for this study.
Eligibility
  • Patients, both male and female, either with or without proliferative diabetic retinopathy
  • Ages 18 years old and older
  • Participants must not:
    • Have any other eye diseases (e.g. glaucoma);
    • Have any other neurologic disease (e.g. Parkinsons, Alzheimers, etc);
    • Be pregnant or nursing an infant
Study Contact: Max Stem, M.D., (734)764–7195, maxstem@med.umich.edu
Principal Investigator: Thomas Gardner, M.D.
Recruitment: Closed
Multicenter Uveitis Steroid Treatment (MUST) Trial Protocol
IRB Number: HUM00001490
The Multicenter Uveitis Steroid Treament (MUST) trial will compare the effectiveness of standard treatment (oral medication) versus fluocinolone acetonide implant therapy for the treatment of severe cases of non-infectious intermediate uveitis, posterior uveitis or panuveitis.

Study Coordinator:  Pam Titus, 734-936-0138, pamtitus@med.umich.edu
Principal Investigator:  Susan Elner, M.D.
Study Sponsor:  National Eye Institute of the National Institutes of Health
Recruitment: Closed
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, pamtitus@med.umich.edu
Principal Investigator: Grant M. Comer, M.D.

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Thyroid Eye Disease

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.

Eligibility
  • Currently have Thyroid Eye Disease
  • Patients, both male and female
  • All ages welcome
Last Modified: Wednesday, 04-Jun-2014 11:40:59 EDT