Direct Application of Selective Laser Trabeculoplasty in Open Angle Glaucoma

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.

Study Overview

• Status: Completed
• Conditions: Glaucoma
• Intervention / Treatment: Device: Direct Selective Trabeculoplasty device

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Ramat-Gan, Israel, 52621
    • The Sam Rothberg Glaucoma Center Goldschleger Eye Institute Sheba meical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Direct Selective Trabeculoplasty; Treatment by an Direct Selective Trabeculoplasty device	Device: Direct Selective Trabeculoplasty device; Patients will be treated with a Direct Selective Trabeculoplasty (DLTP) laser. Placement of the spots is on the sclera around the limbus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of Intra-Ocular pressure	Percentage reduction of intra-ocular pressure following the non contact selective laser trabeculoplasty treatment	1,3 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of Intra-Ocular pressure	Percentage reduction of intra-ocular pressure following the non contact selective laser trabeculoplasty treatment	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of medications	Number of medications after treatment, as compared to before treatment.	6 months
Physician perception of the usability of the system.	Physician perception of the usability of the system.	1 month

Collaborators and Investigators

• Sponsor: Belkin Laser Ltd.
• Collaborators: Horizon 2020 - European Commission
• Investigators: Principal Investigator: Alon Skaat, MD, Sheba Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (ACTUAL): August 1, 2019
• Study Completion (ACTUAL): November 1, 2019

Study Registration Dates

• First Submitted: June 22, 2011
• First Submitted That Met QC Criteria: June 26, 2011
• First Posted (ESTIMATE): June 28, 2011

Study Record Updates

• Last Update Posted (ACTUAL): February 26, 2020
• Last Update Submitted That Met QC Criteria: February 23, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: intraocular pressure; Laser; Trabeculoplasty; SLT, LTP, DSLT; non contact
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: SHEBA-11-8414

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO