Trial record 2 of 3 for:
solx
SOLX Gold Shunt Versus Control Implant: Randomized Trial for Refractory Glaucoma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by SOLX, Inc..
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
SOLX, Inc.
Information provided by:
SOLX, Inc.
ClinicalTrials.gov Identifier:
NCT00382395
First received: September 27, 2006
Last updated: June 7, 2011
Last verified: June 2011
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Purpose
Study Objective:
To establish the substantial equivalence of the SOLX Gold Shunt to commercially available aqueous shunts, specifically the Ahmed™ Glaucoma Valve Model FP7, in the ability to reduce intraocular pressure (IOP) associated with glaucoma in eyes where medical and conventional surgical treatments have failed.
| Condition | Intervention | Phase |
|---|---|---|
|
Glaucoma Glaucoma, Open Angle |
Device: SOLX Gold Shunt GMS-plus Device: Ahmed FP7 Glaucoma Valve |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized, Controlled, Multicenter Comparative Trial to Evaluate the SOLX Gold Shunt for the Reduction of Intraocular Pressure (IOP) in Glaucomatous Eyes Following Failed Medical and Conventional Surgical Treatments |
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:
- Percentage reduction in IOP at both 12 and 24 months after implant [ Time Frame: 1 & 2 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Absolute IOP [ Time Frame: 1 & 2 years ] [ Designated as safety issue: No ]
- Mean number of glaucoma medications [ Time Frame: 1 & 2 years ] [ Designated as safety issue: No ]
- Success rate [ Time Frame: 1 & 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 180 |
| Study Start Date: | November 2005 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
SOLX Gold Shunt
|
Device: SOLX Gold Shunt GMS-plus
Single use implant
|
|
Active Comparator: 2
Control Ahmed FP7 Shunt
|
Device: Ahmed FP7 Glaucoma Valve
Single use implant
|
Detailed Description:
This protocol is a randomized, controlled, multi-center, outpatient study to compare the IOP lowering ability and safety profile of the SOLX Gold Shunt to the selected, commercially available aqueous shunt product (i.e., Control shunt Model FP7 Ahmed™ Glaucoma Valve Flexible Plate™) for a period of up to one year. Extended follow up is scheduled for a period not to exceed two years, should this be necessary for regulatory purposes. Follow-up beyond one year will be expected unless other patients with SOLX Gold Shunt implants in earlier phase studies outside the US clearly show no significant adverse effects associated with the long-term use of the device for follow-up periods exceeding one year, and this information is deemed adequate to reduce the required follow-up period under this protocol to a shorter period, such as 6 months for the last-to-enter patients at the time of filing for 510(k) marketing clearance review with the FDA.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Primary open-angle, pseudoexfoliative, or pigmentary glaucoma
- Age 21 or over
- refractory glaucoma, with IOP >21 mmHg on medications and failed prior incisional glaucoma surgery
- detectable visual field defect (negative MD score)
- written consent
- available for up to 24 months follow-up
Exclusion Criteria:
- either eye with VA worse than count fingers
- recent angle closure glaucoma episode
- uveitic glaucoma, iridocorneal endothelial (ICE) syndrome, traumatic glaucoma, or neovascular 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: NCT00382395
Locations
| United States, California | |
| North Bay Eye Associates | |
| Petaluma, California, United States, 94954 | |
| United States, Colorado | |
| Glaucoma Consultants of Colorado | |
| Littleton, Colorado, United States, 80120 | |
| United States, Florida | |
| International Eye Care | |
| Tampa, Florida, United States, 33603 | |
| United States, Indiana | |
| Price Vision Group | |
| Indianapolis, Indiana, United States, 46260 | |
| United States, New Jersey | |
| University of Medicine and Dentistry of New Jersey | |
| Newark, New Jersey, United States, 07103 | |
| United States, New York | |
| Glaucoma Associates of New York | |
| New York, New York, United States, 10003 | |
| United States, Oklahoma | |
| Eagle Mountain Vision | |
| Tulsa, Oklahoma, United States, 74132 | |
| United States, Pennsylvania | |
| University of Pittsburgh Medical Center | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, Tennessee | |
| University of Tennessee / Hamilton Eye Institute | |
| Memphis, Tennessee, United States, 38163 | |
| Canada, Ontario | |
| Credit Valley EyeCare | |
| Mississauga, Ontario, Canada, L5L 1W8 | |
| Canada, Quebec | |
| Institut du Glaucome de Montréal | |
| Montréal, Quebec, Canada, H1V 1G5 | |
| India | |
| Bombay City Eye Institute & Research Centre | |
| Mumbai, Maharashtra, India, 400 007 | |
| Vision Research Foundation / Sankara Nethralaya | |
| Chennai, Tamil Nadu, India, 600 006 | |
| Israel | |
| Chaim Sheba Medical Center | |
| Tel Hashomer, Israel, 52621 | |
| Poland | |
| Military Institute of the Health Services | |
| Warsaw, Poland, 09-909 | |
Sponsors and Collaborators
SOLX, Inc.
Investigators
| Study Director: | Jan S. Peterson, MS, RAC | The EMMES Corporation |
More Information
No publications provided
| Responsible Party: | Doug Adams, SOLX, Inc. |
| ClinicalTrials.gov Identifier: | NCT00382395 History of Changes |
| Other Study ID Numbers: | SLX53 |
| Study First Received: | September 27, 2006 |
| Last Updated: | June 7, 2011 |
| 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 June 18, 2013