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Cornea Donor Study (IRBMED 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: Cindy Pope, C.O.A.
Principal Investigator: Alan Sugar, M.D.
Study Sponsor: NEI
Recruitment: Closed
Multi-center Study to map novel genes for Fuchs’ Endothelial Corneal Dystrophy (FECD) (IRBMED HUM00002787)
Fuchs‚ Endothelial Corneal Dystrophy afflicts approximately one percent of the general population, including entire families, and can cause blindness. This study is trying to understand the genetics and is mapping genes in families affected by this disease and comparing them to control patients without FUCHs dystrophy.
Contact: Satavisha Dutta, M.S.
Principal Investigator: Alan Sugar, M.D.
Recruitment: Open
LX 201-01 A Multi-center, placebo-controlled, randomized, parallel-group dose-ranging study to assess the efficacy and safety of LX201 for prevention of corneal allograft rejection episodes and graft failure following penetrating keratoplasty (IRBMED HUM00011861)
This study is looking at the benefit for use of an implant called LX201 versus placebo at the time of corneal transplant to prevent rejection. The LX201 implant is made of silicone and either releases a medication called cyclosporine A that is commonly used to help prevent rejection of transplanted organs by the body or a placebo.
Contact: Satavisha Dutta, M.S.
Principal Investigator: Alan Sugar, M.D.
Recruitment: Open
LX 201-02 A multi-center study to assess the efficacy and safety of LX201 for the prevention of corneal allograft rejection episodes or graft failure in subjects who have experienced one or more rejection episodes following penetrating keratoplasty (IRBMED HUM00012320)
This study is looking at the use of an implant called LX201 to prevent further rejections and failure of previous corneal transplants. The implant is made of silicone and is either a placebo or releases a medication called cyclosporine A which is commonly used to help prevent the rejection of transplanted organs by the body.
Contact: Satavisha Dutta, M.S.
Principal Investigator: Alan Sugar, M.D.
Recruitment: Open
Femtosecond Laser Assisted Keratoplasty (IRBMED 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.
Contact: Satavisha Dutta, M.S.
Principal Investigator: Shahzad I. Mian, M.D.
Recruitment: Open
The pathogenesis of Idiopathic Dry Eyes (IRBMED 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.
Contact: Satavisha Dutta, M.S.
Principal Investigator: Roni Shtein, M.D.
Recruitment: Open
Multifocal Visual-evoked Potential in Detecting Early Glaucoma Damage (IRBMED HUM00006900)
The purpose of this study is to compare four methods of measuring vision loss due to glaucoma. These tests will show if there has been damage to your optic nerve, or the outer areas of your retina, and the pattern of damage. These methods are being evaluated so that tests can be developed that provide objective assessment of both visual function and nerve damage.
Contact: Carol J. Pollack-Rundle, B.S., C.O.M.T., 734-763-5874
Principal Investigator: Jennifer S. Weizer, M.D.
Recruitment: Open
The purpose of this multicenter trial is three-fold: 1) to determine if eye drops to lower intraocular pressure (IOP) prevent or delay damage due to glaucoma in patients with high IOP; 2) to identify the risk factors for developing glaucomatous damage; and 3) to determine whether our treatment of these patients with high IOPs results in ocular or systemic complications. Thus far, we have determined that treatment with pressure-lowering eye drops does delay progression to glaucoma damage for the first five years. We have also found that the thickness of the cornea is a definite risk factor for developing glaucomatous damage. As the study continues, we will evaluate other probable risk factors and possible complications.
Contact: C.J. Pollack-Rundle, C.O.M.T., 734-936-9805
Principal Investigator: Terry J. Bergstrom, M.D.
Study Sponsor: National Eye Institute, NIH
Recruitment: Closed to new participants
End Date: 12/31/2008
Multicenter Uveitis Steroid Treatment (MUST) Trial Protocol (IRBMED HUM00001490)
The primary objective of the Multicenter Uveitis Steroid Treatment (MUST) Trial is to 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.
Patients with active uveitis will be randomized, with a 1:1 allocation ratio, to treatment with either the fluocinolone acetonide implant (a small device implant that contains medication) or standard treatment (oral medication) consisting of oral corticosteroids and supplementary immunosuppressive drugs when indicated, according to standardized guidelines.
Contact: Julie Gothrup, 734-936-9798
Principal Investigator: Susan Elner, M.D.
Study Sponsor: National Eye Institute of the National Institutes of Health
Recruitment: Open
Prevalence of Obstructive Sleep Apnea in Patients with Central Serous Chorioretinopathy (IRBMED HUM00003666)
This research study is to determine whether there is an association between an eye disease called central serous chorioretinopathy and a breathing disorder called obstructive sleep apnea. Any adult patients diagnosed with central serous retinopathy (a condition of fluid leakage in the back of the eye which decreases vision), the retinal condition being studied, and patients without a history of any retinal disease may be eligible to participate.
Contact: Garrett Scott, M.D., 734-764-5208
Principal Investigator: Thellea Leveque, M.D, M.P.H., 734-763-1415
Study Sponsor: University of Michigan General Clinical Research Center
Recruitment: Open
Sleep Apnea as a Potential Risk Factor for Central Serous Chorioretinopathy (IRBMED 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.
Contact: Thellea Leveque, M.D, M.P.H., 734-763-1415
Principal Investigator: David N. Zacks, M.D., Ph.D.
Recruitment: Open
A Study of Encapsulated Cell Technology Implant for Participants with Early Stage Retinitis Pigmentosa (IRBMED HUM00010845)
This study will assess the safety and effectiveness of ciliary neurotrophic factor (CNTF) implants in patients with retinitis pigmentosa, Usher Type II III, and choroideremia. Currently there are no effective therapies for people with these retinal degenerations. They are genetic disorders that affect night vision and later cause tunnel vision and loss of central vision.
The implant is a small capsule that contains human retinal pigment epithelium cells. These cells have been given the ability to make CNTF, which they release through the capsule membrane into the surrounding ocular fluid. In this study, two different CNTF dose levels will be used: a high dose and a low dose in one eye, as well as a sham (placebo) surgery in the other eye.
Eligibility criteria:- to men and women between 18 and 64 years
- patients with a diagnosis of RP, Usher Syndrome Type II or III, or choroideremia
- individuals whose visual acuity is no worse than 20/63
- individuals who have had at least two full-threshold Humphrey Visual Field 30-2 tests, one completed within the year before enrolling in this study
Exclusion criteria:
- women who are pregnant or breastfeeding or who do not use contraception
- individuals with other eye diseases, including advanced cataract
- individuals with RP caused by a classic syndrome, including Usher Type I
- individuals with a chronic systemic disease that requires treatment with systemic steroids, immunosuppressive medications or insulin
Contact: Pam Titus, 734-763-5906
Principal Investigator: John R. Heckenlively, M.D.
Study Sponsor: Neurotech Pharmaceuticals
Recruitment: Open
A Study of Encapsulated Cell Technology Implant for Participants with Late Stage Retinitis Pigmentosa (IRBMED HUM00010845)
This study will assess the safety and effectiveness of ciliary neurotrophic factor (CNTF) implants in patients with retinitis pigmentosa, Usher Type II III, and choroideremia. Currently there are no effective therapies for people with these retinal degenerations. They are genetic disorders that affect night vision and later cause tunnel vision and loss of central vision.
The implant is a small capsule that contains human retinal pigment epithelium cells. These cells have been given the ability to make CNTF, which they release through the capsule membrane into the surrounding ocular fluid. In this study, two different CNTF dose levels will be used: a high dose and a low dose in one eye, as well as a sham (placebo) surgery in the other eye.
Eligibility criteria:
- men and women between 18 and 64 years
- patients with a diagnosis of RP, Usher Syndrome Type II or III, or choroideremia
- individuals whose visual acuity is no better than 20/80 and no worse than 20/320
- individuals who have reduced electrical responses from the retina (ERG) and loss of peripheral vision
Exclusion criteria:
- women who are pregnant or breastfeeding or who do not use contraception
- individuals with other eye diseases, including advanced cataract
- individuals with RP caused by a classic syndrome, including Usher Type I
- individuals with a chronic systemic disease that requires treatment with systemic steroids, immunosuppressive medications or insulin
Contact: Pam Titus, 734-763-5906
Principal Investigator: John R. Heckenlively, M.D.
Study Sponsor: Neurotech Pharmaceuticals
Recruitment: Open
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