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.
Jump to a section by selecting an eye condition
Cornea and External Disease Trials
Diagnostic Imaging for Intraoperative Floppy Iris Syndrome
(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;
Contact: Munira Hussain, 734-647-8397
Principal Investigator: Roni Shtein, M.D.
Recruitment: Open
In Vivo Corneal Confocal Microscopy for Non-invasive Assessment of Diabetic Peripheral Neuropathy
(HUM00042377)
The goal of this study is to develop a non-invasive diagnostic protocol as a way to evaluate diabetic peripheral neuropathy. 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.
Contact: Munira Hussain, 734-647-8397
Principal Investigator: Roni Shtein, M.D.
Recruitment: Open
Long-term outcomes after laser in situ keratomileusis (LASIK): mechanical microkeratome vs femtosecond laser
(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;
Contact: Munira Hussain, 734-647-8397
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
Contact: Munira Hussain, 734-647-8397
Principal Investigator: Roni Shtein, M.D.
Recruitment: Open
Expected Recruitment End Date: 12/31/2011
Cornea Donor Study
IRB Number: 2000-022
This is a 10-year follow-up study of patients following corneal transplant to determine whether the graft-failure rate is the same when using corneal tissue from donors older than 65 years of age compared with tissue from younger donors.
Contact: Munira Hussain, 734-647-8397
Principal Investigator: Alan Sugar, M.D.
Study Sponsor:NEI
Recruitment: Closed
Femtosecond Laser Assisted Keratoplasty
IRB Number: HUM00015615
The purpose of this study will be to determine optimal surgical technique for performing FLAK (Femtosecond Laser Assisted Keratoplasty) including laser parameters, keratoplasty shape and suture techniques in preliminary human studies, in order to standardize surgical technique and to collect safety and efficacy data. Visit UMClinicalStudies web site for additional information and eligibility requirements.
Contact: Munira Hussain, 734-647-8397
Principal Investigator: Shahzad I. Mian, M.D.
Recruitment: Closed
The Process of Development of Dry Eyes
IRB Number: HUM00013091
We will evaluate patients with dry eye symptoms 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. Visit UMClinicalStudies web site for additional information and eligibility requirements.
Contact: Munira Hussain, 734-647-8397
Principal Investigator: Roni Shtein, M.D.
Recruitment: Open
Expected Recruitment End Date: 12/31/2011
Retina Trials
Diabetic Retinal Sensory Neuropathy
IRB Number: HUM00051733
The goals of this study are to develop improved means of detecting diabetic retinopathy (DR) in its earliest stages and to better understand how nerve damage from diabetes relates to eye damage from diabetes. This is a two year study that will include eye exams and specialized eye tests (such as dark adaptation, visual fields, and electroretinography) at enrollment, one year, and two years of participation. This study will provide new information about the earliest changes that diabetes exerts on the retina (back part of the eye) and on other nerves in the body. It may eventually lead to new ways of diagnosing, preventing, and treating diabetic retinopathy and neuropathy. Participation in this study is contingent upon participation in HUM00036408 (Cardiac Autonomic Neuropathy and Myocardial Dysfunction in Type I DM). Please contact Cindy Plunket (cplunket@med.umich.edu) for information about participating in that study.
Eligibility:
- Age Range: From 18 To 65 years
- Gender: Both Female and Male
- Ethnicity: All
- Race: All
- Smoking: Both Smoking and No-Smoking
- This study is seeking: Patient with Specific Condition
- Best Corrected Visual Acuity (i.e. with glasses or contacts) must be better than 20/30
- Patients with Diabetes must NOT have any evidence of complications (i.e. retinopathy, neuropathy, or nephropathy)
- Type I Diabetes Mellitus duration of 5 - 10 years
Contact: Max Stem, M.D., 734–234–7195
Principal Investigator: Thomas Gardner, M.D., M.S.
Recruitment: Open
Vital Imaging of Retinal/Optic Nerve Diseases
IRB Number: HUM00039819
Researchers at the Kellogg Eye Center are evaluating an eye camera that has been modified to detect fluorescent signals from the retina (back of the eye). These signals serve as a functional marker to tell us about the retina's health or degree of disease progression that may be caused by eye diseases. Currently, we are studying these signals in diabetes complications of the eye, and if they can be used as an early predictor for diabetes.
Eligibility:
- Age Range: From 45-70 years
- Gender: Both Female and Male
- Ethnicity: All
- Race: All
- Smoking: Both Smoking and No-Smoking
- This study is seeking: Patients with no known personal history of diabetes or ophthalmic eye disease
- Patients must not have intraocular lenses following cataract surgery
- A fasting plasma glucose measurement within one year of study participation is required.
Contact: Michelle Cote, 810-569-2583
Principal Investigator: John R. Heckenlively, M.D.
Recruitment: Open
Expected Recruitment End Date: 12/23/2011
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.
Contact: Pamela Titus, COT, 734-936-0138
Principal Investigator: Grant M. Comer, M.D.
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. Visit U-M Engage for additional information and eligibility requirements.
Contact: Julie Gothrup, 734-936-9798
Principal Investigator: Susan Elner, M.D.
Study Sponsor: National Eye Institute of the National Institutes of Health
Recruitment: Closed
Sleep Apnea as a Potential Risk Factor for Central Serous Chorioretinopathy
IRB Number: 2004-0583
This project will use a survey instrument to determine the approximate prevalence of sleep apnea in a CSCR population compared to published data on sleep apnea prevalence in normals. If the rate of sleep apnea is high in patients with CSCR, the possibility exists that sleep apnea is a risk factor for CSCR. If sleep apnea predisposes patients to develop CSCR, perhaps treatment of the apnea could ameliorate or prevent recurrences of CSCR.
An alternate explanation of such a correlation would be that the two diseases share a common risk factor. If an association between the diseases were identified, a sleep-study based, risk factor controlled project would be warranted in order to be certain of the sleep apnea diagnosis, and to eliminate confounding variables.
Principal Investigator: David N. Zacks, M.D., Ph.D.
Recruitment: Open