SOLX Gold Shunt for Refractory Glaucoma
This study is currently recruiting participants.
Verified December 2012 by SOLX, Inc.
Sponsor:
SOLX, Inc.
Information provided by (Responsible Party):
SOLX, Inc.
ClinicalTrials.gov Identifier:
NCT01282346
First received: January 5, 2011
Last updated: December 3, 2012
Last verified: December 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
To establish the clinical performance of the SOLX Gold Shunt for its ability to reduce intraocular pressure (IOP) in eyes with refractory glaucoma where medical and conventional surgical treatments have failed.
| Condition | Intervention | Phase |
|---|---|---|
|
Glaucoma Glaucoma, Open Angle |
Device: SOLX Gold Shunt |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Clinical Evaluation of the SOLX Gold Shunt for the Reduction of Intraocular Pressure (IOP) in Refractory Glaucoma |
Resource links provided by NLM:
Genetics Home Reference related topics:
early-onset glaucoma
MedlinePlus related topics:
Glaucoma
U.S. FDA Resources
Further study details as provided by SOLX, Inc.:
Primary Outcome Measures:
- Proportion of eyes that achieve an IOP of > 5mmHg and ≤ 21 mmHg, irrespective of medication use [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Average change in IOP [ Time Frame: 1 & 2 years ] [ Designated as safety issue: No ]
- Percentage change in IOP from baseline [ Time Frame: 1 & 2 years ] [ Designated as safety issue: No ]
- Average change in number of glaucoma medications [ Time Frame: 1 & 2 years ] [ Designated as safety issue: No ]
- Visual acuity changes [ Time Frame: 1 & 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2011 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: SOLX Gold Shunt |
Device: SOLX Gold Shunt
Single use implant
|
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- primary open-angle glaucoma
- age 21 or over
- refractory glaucoma, with IOP ≥ 24 mmHg on medications and failed prior incisional glaucoma surgery
- detectable visual field defect (negative MD score)
- written informed consent
- available for up to 24 months follow-up
Exclusion Criteria:
- either eye with VA worse than count fingers
- angle closure glaucoma episode within past 12 months
- uveitic glaucoma, iridocorneal endothelial (ICE) syndrome, traumatic glaucoma, or neovascular glaucoma
- diagnosis of pigmentary glaucoma or pseudoexfoliative glaucoma
- other significant ocular disease, except cataract
- active ocular infection
- expected ocular surgery in next 12 months
- no suitable quadrant for implant
- systemic corticosteroid therapy > 5 mg/day prednisone
- intolerance to gonioscopy or other eye exams
- mental impairment interfering with consent or compliance
- pregnancy
- known sensitivity to anticipated medications used at surgery
- significant co-morbid disease
- concurrent enrollment in another drug or device study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01282346
Contacts
| Contact: Howard Kim, MD | 781-609-2016 | howard@solx.com |
| Contact: Doug Adams | 781-609-2016 | doug@solx.com |
Locations
| United States, Alabama | |
| University of Alabama | Recruiting |
| Birmingham, Alabama, United States, 35233 | |
| Contact: Stacy Eddleman 205-325-8310 stacye@uab.edu | |
| Principal Investigator: Christopher Girkin, MD | |
| United States, Arkansas | |
| Vold Vision, PLLC | Recruiting |
| Springdale, Arkansas, United States, 72762 | |
| Contact: Scott Hewitt 479-756-8653 sahewitt26@gmail.com | |
| Principal Investigator: Steven Vold, MD | |
| United States, California | |
| University of California, Irvine | Recruiting |
| Irvine, California, United States, 92697 | |
| Contact: Jeff Grijalva, COT, CCRA 714-456-7741 jgrijalv@uci.edu | |
| Principal Investigator: Sameh Mosaed, MD | |
| United States, Connecticut | |
| Yale University | Recruiting |
| New Haven, Connecticut, United States, 06510 | |
| Contact: Jennifer Dupont 203-785-6150 jennifer.dupont@yale.edu | |
| Principal Investigator: James C Tsai, MD | |
| United States, Illinois | |
| Illinois Eye Institute | Recruiting |
| Chicago, Illinois, United States, 60616 | |
| Contact: Anesu Mvududu 312-949-7298 amvududu@ico.edu | |
| Principal Investigator: Lili Farrokh-Siar, MD | |
| United States, Pennsylvania | |
| Ophthalmic Partners of Pennsylvania | Recruiting |
| Bala Cynwyd, Pennsylvania, United States, 19004 | |
| Contact: Irene Spanelis 484-434-2706 ISpanelis@oppdoctors.com | |
| Principal Investigator: Marlene Moster, MD | |
| Sub-Investigator: Michael Pro, MD | |
| United States, Tennessee | |
| University Eye Surgeons | Recruiting |
| Maryville, Tennessee, United States, 37803 | |
| Contact: Marta Johnson, COT 865-681-1234 mmj27707@bellsouth.net | |
| Principal Investigator: Ken Olander, MD | |
| United States, Texas | |
| Glaucoma Associates of Texas | Recruiting |
| Dallas, Texas, United States, 75231 | |
| Contact: Elizabeth Owens, CCRP, BA 214-765-9717 eowens@glaucomaassociates.com | |
| Principal Investigator: Oluwatosin Smith, MD | |
| United States, Virginia | |
| University of Virginia | Recruiting |
| Charlottsville, Virginia, United States, 22908 | |
| Contact: Kristina Holbrook 434-243-2852 klh7v@virginia.edu | |
| Principal Investigator: Peter Netland, MD | |
| United States, Wisconsin | |
| Memmen, Ltd | Recruiting |
| Green Bay, Wisconsin, United States, 54304 | |
| Contact: Angel Henry 920-497-0100 angelh@memmenmd.com | |
| Principal Investigator: James Memmen, MD | |
| Brazil | |
| University of Campinas | Recruiting |
| Campinas, Brazil | |
| Contact: Kleyton Barella, MD kbarella@terra.com.br | |
| Principal Investigator: Vital P Costa, MD | |
| Canada, Ontario | |
| Credit Valley Eyecare / Osler Eyecare | Recruiting |
| Mississauga, Ontario, Canada, L5L 1W8 | |
| Contact: Donna Williams-Lyn, PhD 905-820-3937 ext 154 dwlcvec@gmail.com | |
| Principal Investigator: Iqbal (Ike) Ahmed, MD | |
| Clarity Eye Institute | Recruiting |
| Vaughan, Ontario, Canada, L4K 0C5 | |
| Contact: Heather Coulter 416-663-3937 ext 225 coulter.heather@gmail.com | |
| Principal Investigator: Baseer Khan, MD FRCS(C) | |
| Canada, Quebec | |
| Bellevue Ophthalmology Clinic | Recruiting |
| Montreal, Quebec, Canada, H1V 1G5 | |
| Contact: Nataliya Khrushch (514) 256-1908 nkhrushch@igmtl.com | |
| Principal Investigator: Paul Harasymowycz, MD | |
| Bellevue Ophthalmology Clinic | Recruiting |
| Montreal, Quebec, Canada, H1V 1G5 | |
| Contact: Nataliya Khrushch (514) 256-1908 nkhrushch@hotmail.com | |
| Principal Investigator: Paul Harasymowycz, MD | |
| Israel | |
| Medical Research Infrastructure Department and Health Services Fund by the Sheba Medical Center (R.A.) | Recruiting |
| Tel-Hashomer, Israel, 52621 | |
| Contact: Koran Tal Eyes.Studies@sheba.health.gov.il | |
| Principal Investigator: Shlomo Melamed, MD | |
| Spain | |
| Instituto Gabriel Simon | Withdrawn |
| Madrid & Barcelona, Spain | |
Sponsors and Collaborators
SOLX, Inc.
Investigators
| Study Director: | Nilay Shah, MD | The EMMES Corporation |
More Information
No publications provided
| Responsible Party: | SOLX, Inc. |
| ClinicalTrials.gov Identifier: | NCT01282346 History of Changes |
| Other Study ID Numbers: | SLX84 |
| Study First Received: | January 5, 2011 |
| Last Updated: | December 3, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by SOLX, Inc.:
|
Glaucoma shunt Ocular implant Gold Trabeculectomy |
Additional relevant MeSH terms:
|
Glaucoma Glaucoma, Open-Angle Ocular Hypertension Eye Diseases |
ClinicalTrials.gov processed this record on May 16, 2013