GlaucomaPhase 3NCT00145535
SOLX Titanium Sapphire Laser for Trabeculoplasty
A Phase 3 study testing SOLX Titanium Sapphire Laser (TiSaLT) and Argon Laser Trabeculoplasty (ALT) in people with Glaucoma and Glaucoma, Open Angle, run by SOLX, Inc. at 10 sites in 4 countries.
Trial summary
Use of the Titanium Sapphire laser for laser trabeculoplasty to reduce intraocular pressure in patients with poorly controlled intraocular pressure on maximally tolerated medical therapy or prior failed laser trabeculoplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Glaucoma, Open Angle
- What is being tested?
- SOLX Titanium Sapphire Laser (TiSaLT) and Argon Laser Trabeculoplasty (ALT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 10 sitesin 4 countries
- Study dates
- May 2004to Jun 2009
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Patients are not eligible for enrollment if any of the following exclusion criteria are met:
- Eye to be treated has any of the following:
- evidence of glaucoma other than open-angle glaucoma;
- severe paracentral or generalized field defect;
- any ocular condition that precluded adequate visualization and treatment of the trabecular meshwork.
- prior glaucoma surgery other than laser trabeculoplasty or peripheral iridotomy.
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- Patient has mental impairment such that he/she could not understand the protocol or is not in a position to provide written informed consent.
- Patient is pregnant.
- Patient might require other ocular surgery within the 6-month follow-up period.
- Patient has a medical history that suggested the potential for complications from TiSaLT.
- Having concurrent treatment with systemic steroids.
Trial locations and contacts
10 sites in 4 countries.
10 sites in 4 countries
United States5 sites
Texan Eye Care
Austin, Texas, 78705
Mann Eye Institute
Houston, Texas, 77002
Glaucoma Associates of New York
New York, New York, 10003
North Bay Eye Associates
Petaluma, California, 94954
International Eye Care
Tampa, Florida, 33603
Canada2 sites
Credit Valley EyeCare
Mississauga, Ontario, L5L 1W8
Institut du Glaucome de Montréal
Montreal, Quebec, H1V 1G5
Israel2 sites
Sourasky Medical Center
Tel Aviv, 64239
Sheba Medical Center
Tel HaShomer, 52621
About this study
Use of the Titanium Sapphire laser for laser trabeculoplasty to reduce intraocular pressure in patients with poorly controlled intraocular pressure on maximally tolerated medical therapy or prior failed laser trabeculoplasty.
Read the detailed description
This is a multi-center, outpatient study assessing equivalence of the Titanium Sapphire laser (TiSaLT) to the Argon laser (ALT) in the ability to reduce IOP in patients having primary open angle glaucoma in eyes with poorly controlled IOP on maximally tolerated medications and/or prior failed glaucoma surgery. Approximately 120 patients are to be enrolled in the study, with approximately equal numbers of patients enrolled at each of the investigational sites. The investigational sites are to accrue patients with poorly controlled open-angle glaucoma on maximal tolerated medical therapy and/or patients with previously failed laser trabeculoplasty. One half of the eyes will be randomized to treatment with the Argon laser (ALT) as the concurrent control group and the other half will be treated with Titanium Sapphire (TiSaLT) laser.
- Conditions
- Glaucoma, Glaucoma, Open Angle
- Being tested
- SOLX Titanium Sapphire Laser (TiSaLT), Argon Laser Trabeculoplasty (ALT)
- Keywords
- Glaucoma, Glaucoma, open angle, Intraocular Pressure, Trabeculoplasty, laser, laser, surgery
- 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 Titanium Sapphire Laser (TiSaLT)Device
Spot laser treatment, ~50 spots over 180°
Argon Laser Trabeculoplasty (ALT)Device
Spot laser treatment, ~50 spots over 180°
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Titanium sapphire laser treatment Receives: Device: SOLX Titanium Sapphire Laser (TiSaLT) |
| 2 | Active comparator | Argon laser treatment Receives: Device: Argon Laser Trabeculoplasty (ALT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular Pressure (IOP)
Measured: 1 year
Secondary outcomes (1)
Adverse event frequency
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2005 (estimated)
- Study startMay 2004
- Primary completionJun 2009
- Study completionJun 2009
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SOLX, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jan S Peterson, MS, RAC, Study director, The Emmes Company, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00145535
- Sponsor's protocol ID
- SLX41
- Status last verified
- Jul 2009
- First submitted
- 1 Sep 2005
- Last updated
- 29 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SOLX Titanium Sapphire Laser for Trabeculoplasty
- ClinicalTrials.gov ID
- NCT00145535
- Acronym / sponsor ID
- SLX41
- Conditions
- Glaucoma, Glaucoma, Open Angle
- Keywords
- Glaucoma, Glaucoma, open angle, Intraocular Pressure, Trabeculoplasty, laser, laser, surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- SOLX, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2004
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 5 Sep 2005 (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.
Use of the Titanium Sapphire laser for laser trabeculoplasty to reduce intraocular pressure in patients with poorly controlled intraocular pressure on maximally tolerated medical therapy or prior failed laser trabeculoplasty.
Detailed description
This is a multi-center, outpatient study assessing equivalence of the Titanium Sapphire laser (TiSaLT) to the Argon laser (ALT) in the ability to reduce IOP in patients having primary open angle glaucoma in eyes with poorly controlled IOP on maximally tolerated medications and/or prior failed glaucoma surgery. Approximately 120 patients are to be enrolled in the study, with approximately equal numbers of patients enrolled at each of the investigational sites. The investigational sites are to accrue patients with poorly controlled open-angle glaucoma on maximal tolerated medical therapy and/or patients with previously failed laser trabeculoplasty. One half of the eyes will be randomized to treatment with the Argon laser (ALT) as the concurrent control group and the other half will be treated with Titanium Sapphire (TiSaLT) laser.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: SOLX Titanium Sapphire Laser (TiSaLT)Titanium sapphire laser treatment |
| 2 | Active comparator | Device: Argon Laser Trabeculoplasty (ALT)Argon laser treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (11 listed)
- Patients are not eligible for enrollment if any of the following exclusion criteria are met:
- Eye to be treated has any of the following:
- Patient has mental impairment such that he/she could not understand the protocol or is not in a position to provide written informed consent.
- Patient is pregnant.
- Patient might require other ocular surgery within the 6-month follow-up period.
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 Titanium Sapphire Laser (TiSaLT)Spot laser treatment, ~50 spots over 180° | Device | 1 |
| Argon Laser Trabeculoplasty (ALT)Spot laser treatment, ~50 spots over 180° | Device | 2 |
Primary outcome
Intraocular Pressure (IOP)
Time frame: 1 year
1 secondary outcome
Adverse event frequency
Time frame: 1 year
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 29 Jan 2010.
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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.
Jan S Peterson, MS, RAC study director
The Emmes Company, LLC
10 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SOLX Titanium Sapphire Laser (TiSaLT) and Argon Laser Trabeculoplasty (ALT) in people with Glaucoma and Glaucoma, Open Angle, run by SOLX, Inc. at 10 sites in 4 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 0 inclusion and 11 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 29 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Canada, Israel, Spain. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Intraocular Pressure (IOP) (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 29 Jan 2010.