Back to resultsDirect Application of Selective Laser Trabeculoplasty in Open Angle Glaucoma
Primary Purpose
Glaucoma
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Direct Selective Trabeculoplasty device
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma focused on measuring SLT, LTP, DSLT, non contact, Trabeculoplasty, Laser, intraocular pressure
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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
Sites / Locations
- The Sam Rothberg Glaucoma Center Goldschleger Eye Institute Sheba meical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Direct Selective Trabeculoplasty
Arm Description
Treatment by an Direct Selective Trabeculoplasty device
Outcomes
Primary Outcome Measures
Reduction of Intra-Ocular pressure
Percentage reduction of intra-ocular pressure following the non contact selective laser trabeculoplasty treatment
Secondary Outcome Measures
Reduction of Intra-Ocular pressure
Percentage reduction of intra-ocular pressure following the non contact selective laser trabeculoplasty treatment
Full Information
NCT ID
NCT01383525
First Posted
June 22, 2011
Last Updated
February 23, 2020
Sponsor
BelkinVision
Collaborators
Horizon 2020 - European Commission
1. Study Identification
Unique Protocol Identification Number
NCT01383525
Brief Title
Direct Application of Selective Laser Trabeculoplasty in Open Angle Glaucoma
Official Title
Direct Application of Selective Laser Trabeculoplasty in Open Angle Glaucoma . Single Site Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
August 2019 (Actual)
Study Completion Date
November 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BelkinVision
Collaborators
Horizon 2020 - European Commission
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
SLT, LTP, DSLT, non contact, Trabeculoplasty, Laser, intraocular pressure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
No masking for treatment. The follow-up and primary endpoint assessment, intra-ocular pressure (IOP) measurement, is performed by masked ophthalmologist.
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Direct Selective Trabeculoplasty
Arm Type
Experimental
Arm Description
Treatment by an Direct Selective Trabeculoplasty device
Intervention Type
Device
Intervention Name(s)
Direct Selective Trabeculoplasty device
Intervention Description
Patients will be treated with a Direct Selective Trabeculoplasty (DLTP) laser. Placement of the spots is on the sclera around the limbus.
Primary Outcome Measure Information:
Title
Reduction of Intra-Ocular pressure
Description
Percentage reduction of intra-ocular pressure following the non contact selective laser trabeculoplasty treatment
Time Frame
1,3 month
Secondary Outcome Measure Information:
Title
Reduction of Intra-Ocular pressure
Description
Percentage reduction of intra-ocular pressure following the non contact selective laser trabeculoplasty treatment
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Number of medications
Description
Number of medications after treatment, as compared to before treatment.
Time Frame
6 months
Title
Physician perception of the usability of the system.
Description
Physician perception of the usability of the system.
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alon Skaat, MD
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Sam Rothberg Glaucoma Center Goldschleger Eye Institute Sheba meical Center
City
Ramat-Gan
ZIP/Postal Code
52621
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Direct Application of Selective Laser Trabeculoplasty in Open Angle Glaucoma
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