GlaucomaNCT01282346
SOLX Gold Shunt for Refractory Glaucoma
A study testing SOLX Gold Shunt in people with Glaucoma and Glaucoma, Open Angle, run by SOLX, Inc. at 17 sites in 5 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Glaucoma, Glaucoma, Open Angle
- What is being tested?
- SOLX Gold Shunt
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 17 sitesin 5 countries
- Study dates
- Jan 2011to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
17 sites in 5 countries.
17 sites in 5 countries
United States11 sites
Ophthalmic Partners of Pennsylvania
Bala-Cynwyd, Pennsylvania, 19004
University of Alabama
Birmingham, Alabama, 35233
University of Virginia
Charlottsville, Virginia, 22908
Illinois Eye Institute
Chicago, Illinois, 60616
Glaucoma Associates of Texas
Dallas, Texas, 75231
Memmen, Ltd
Green Bay, Wisconsin, 54304
University of California, Irvine
Irvine, California, 92697
University Eye Surgeons
Maryville, Tennessee, 37803
Yale University
New Haven, Connecticut, 06510
Glaucoma Associates of New York
New York, New York, 10003
Vold Vision, PLLC
Springdale, Arkansas, 72762
Canada3 sites
Institut de l'oeil des Laurentides
Boisbriand, Quebec, J7H 1S6
Bellevue Ophthalmology Clinic
Montreal, Quebec, H1V 1G5
Clarity Eye Institute
Vaughan, Ontario, L4K 0C5
Israel1 site
Medical Research Infrastructure Department and Health Services Fund by the Sheba Medical Center (R.A.)
Tel HaShomer, 52621
About this study
Official title: Clinical Evaluation of the SOLX Gold Shunt for the Reduction of Intraocular Pressure (IOP) in Refractory Glaucoma
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.
- Conditions
- Glaucoma, Glaucoma, Open Angle
- Being tested
- SOLX Gold Shunt
- Keywords
- Glaucoma shunt, Ocular implant, Gold, Trabeculectomy
- Medical subject headings
- Glaucoma, Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOLX Gold ShuntDevice
Single use implant
| Study group | Role | What they receive |
|---|---|---|
| SOLX Gold Shunt | Experimental | Not described Receives: Device: SOLX Gold Shunt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of eyes that achieve an IOP of > 5mmHg and ≤ 21 mmHg, irrespective of medication use
Measured: 1 year
Secondary outcomes (4)
Average change in IOP
Measured: 1 & 2 years
Percentage change in IOP from baseline
Measured: 1 & 2 years
Average change in number of glaucoma medications
Measured: 1 & 2 years
Visual acuity changes
Measured: 1 & 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- SOLX, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nilay Shah, MD, Study director, The Emmes Company, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01282346
- Sponsor's protocol ID
- SLX84
- Status last verified
- Feb 2017
- First submitted
- 5 Jan 2011
- Last updated
- 23 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the SOLX Gold Shunt for the Reduction of Intraocular Pressure (IOP) in Refractory Glaucoma
- ClinicalTrials.gov ID
- NCT01282346
- Acronym / sponsor ID
- SLX84
- Conditions
- Glaucoma, Glaucoma, Open Angle
- Keywords
- Glaucoma shunt, Ocular implant, Gold, Trabeculectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- SOLX, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 25 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SOLX Gold Shunt | Experimental | Device: SOLX Gold Shunt |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SOLX Gold ShuntSingle use implant | Device | SOLX Gold Shunt |
Primary outcome
Proportion of eyes that achieve an IOP of > 5mmHg and ≤ 21 mmHg, irrespective of medication use
Time frame: 1 year
4 secondary outcomes
Average change in IOP
Time frame: 1 & 2 years
Percentage change in IOP from baseline
Time frame: 1 & 2 years
Average change in number of glaucoma medications
Time frame: 1 & 2 years
Visual acuity changes
Time frame: 1 & 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nilay Shah, MD study director
The Emmes Company, LLC
17 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SOLX Gold Shunt in people with Glaucoma and Glaucoma, Open Angle, run by SOLX, Inc. at 17 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Canada, Brazil, Israel, Venezuela. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of eyes that achieve an IOP of > 5mmHg and ≤ 21 mmHg, irrespective of medication use (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.