GlaucomaNCT01383525
Direct Application of Selective Laser Trabeculoplasty in Open Angle Glaucoma
A study testing Direct Selective Trabeculoplasty device in people with Glaucoma, run by BelkinVision at 1 site in Israel.
Trial summary
The trial objectives are to establish the safety \& efficacy of using a DLTP laser to perform laser trabeculoplasty to reduce Intraocular Pressure (IOP) in patients with open angle glaucoma (Including Pigmentary \& Exfoliative Glaucoma), that did not achieve adequate IOP control by conventional therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Direct Selective Trabeculoplasty device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2011to Nov 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is aged 18 years or older, with 2 sighted eyes.
- Eye to be treated have average IOP *22 mmHg, measured at 2 pretreatment visits.
- Eye to be treated either exhibits:
- poorly controlled open angle glaucoma including Pigmentary \& Exfoliative Glaucoma
- Patient would be considered eligible for conventional laser trabeculoplasty.
- Patient is willing to participate in the 6-month study and to adhere to the follow-up schedule.
- Patient is willing to review and sign a consent form.
Who cannot join
- evidence of glaucoma other than open-angle glaucoma;
- severe para-central 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.
- 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.
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- 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 Direct Selective Trabeculoplasty (DSLT)
- Having concurrent treatment with systemic steroids.
- Patient is under 18 years old
Trial locations and contacts
1 site in 1 country.
Israel1 site
The Sam Rothberg Glaucoma Center Goldschleger Eye Institute Sheba meical Center
Ramat Gan, 52621
About this study
Official title: Direct Application of Selective Laser Trabeculoplasty in Open Angle Glaucoma . Single Site Study
The trial objectives are to establish the safety \& efficacy of using a DLTP laser to perform laser trabeculoplasty to reduce Intraocular Pressure (IOP) in patients with open angle glaucoma (Including Pigmentary \& Exfoliative Glaucoma), that did not achieve adequate IOP control by conventional therapy.
Read the detailed description
This is a single site outpatient feasibility study assessing the safety \& efficacy of the DLTP laser in the ability to reduce IOP in patients with open angle glaucoma (OAG). The investigational site will accrue patients with uncontrolled OAG. These eyes will be treated with the direct application of Direct Laser Trabeculoplasty (DLTP)/ Direct Selective Laser Trabeculoplasty automated device (DSLT).
Only one eye per patient is to be treated with the investigational device during the study.
The laser parameters used will be like these used in the Selective trabeculoplasty (SLT) device (CE/FDA approved), but all laser beams will be applied in about one-second, through the peri-limbal.
Subjects will be evaluated preoperatively and postoperatively at 1 hour, 2 hours (and hourly to 4 hours in the event of an IOP elevation in the immediate postop course), 1 day, 1 week, and 1, 3, 6 months.
Patients will be followed out to 6 months.
- Conditions
- Glaucoma
- Being tested
- Direct Selective Trabeculoplasty device
- Keywords
- SLT, LTP, DSLT, non contact, Trabeculoplasty, Laser, intraocular pressure
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct Selective Trabeculoplasty deviceDevice
Patients will be treated with a Direct Selective Trabeculoplasty (DLTP) laser. Placement of the spots is on the sclera around the limbus.
| Study group | Role | What they receive |
|---|---|---|
| Direct Selective Trabeculoplasty | Experimental | Treatment by an Direct Selective Trabeculoplasty device Receives: Device: Direct Selective Trabeculoplasty device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of Intra-Ocular pressure
Percentage reduction of intra-ocular pressure following the non contact selective laser trabeculoplasty treatment
Measured: 1,3 month
Secondary outcomes (1)
Reduction of Intra-Ocular pressure
Percentage reduction of intra-ocular pressure following the non contact selective laser trabeculoplasty treatment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2011 (estimated)
- Study startJul 2011
- Primary completionAug 2019
- Study completionNov 2019
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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- BelkinVision
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Horizon 2020 - European Commission
- Responsible party
- Sponsor
- Investigators
- Alon Skaat, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01383525
- Sponsor's protocol ID
- SHEBA-11-8414
- Status last verified
- Feb 2020
- First submitted
- 22 Jun 2011
- Last updated
- 26 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Application of Selective Laser Trabeculoplasty in Open Angle Glaucoma . Single Site Study
- ClinicalTrials.gov ID
- NCT01383525
- Acronym / sponsor ID
- SHEBA-11-8414
- Conditions
- Glaucoma
- Keywords
- SLT, LTP, DSLT, non contact, Trabeculoplasty, Laser, intraocular pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- BelkinVisionIndustry (pharma, biotech, devices)
- Collaborators
- Horizon 2020 - European Commission
- Study start
- Jul 2011
- Primary completion
- Aug 2019 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 28 Jun 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.
The trial objectives are to establish the safety \& efficacy of using a DLTP laser to perform laser trabeculoplasty to reduce Intraocular Pressure (IOP) in patients with open angle glaucoma (Including Pigmentary \& Exfoliative Glaucoma), that did not achieve adequate IOP control by conventional therapy.
Detailed description
This is a single site outpatient feasibility study assessing the safety \& efficacy of the DLTP laser in the ability to reduce IOP in patients with open angle glaucoma (OAG). The investigational site will accrue patients with uncontrolled OAG. These eyes will be treated with the direct application of Direct Laser Trabeculoplasty (DLTP)/ Direct Selective Laser Trabeculoplasty automated device (DSLT).
Only one eye per patient is to be treated with the investigational device during the study.
The laser parameters used will be like these used in the Selective trabeculoplasty (SLT) device (CE/FDA approved), but all laser beams will be applied in about one-second, through the peri-limbal.
Subjects will be evaluated preoperatively and postoperatively at 1 hour, 2 hours (and hourly to 4 hours in the event of an IOP elevation in the immediate postop course), 1 day, 1 week, and 1, 3, 6 months.
Patients will be followed out to 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Direct Selective Trabeculoplasty | Experimental | Device: Direct Selective Trabeculoplasty deviceTreatment by an Direct Selective Trabeculoplasty device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient is aged 18 years or older, with 2 sighted eyes.
- Eye to be treated have average IOP *22 mmHg, measured at 2 pretreatment visits.
- Eye to be treated either exhibits:
- poorly controlled open angle glaucoma including Pigmentary \& Exfoliative Glaucoma
- Patient would be considered eligible for conventional laser trabeculoplasty.
Key exclusion criteria (10 listed)
- evidence of glaucoma other than open-angle glaucoma;
- severe para-central 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.
- Patient has mental impairment such that he/she could not understand the protocol or is not in a position to provide written informed consent.
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 |
|---|---|---|
| Direct Selective Trabeculoplasty devicePatients will be treated with a Direct Selective Trabeculoplasty (DLTP) laser. Placement of the spots is on the sclera around the limbus. | Device | Direct Selective Trabeculoplasty |
Primary outcome
Reduction of Intra-Ocular pressure
Time frame: 1,3 month
Percentage reduction of intra-ocular pressure following the non contact selective laser trabeculoplasty treatment
1 secondary outcome
Reduction of Intra-Ocular pressure
Time frame: 6 months
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 26 Feb 2020.
- Individual participant dataSharing planned: No
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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.
Alon Skaat, MD principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct Selective Trabeculoplasty device in people with Glaucoma, run by BelkinVision at 1 site in Israel.
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 7 inclusion and 10 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 26 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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?
Reduction of Intra-Ocular pressure (time frame: 1,3 month). 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 26 Feb 2020; AzTrials last refreshed its copy on 6 Nov 2026.