Direct Application of Selective Laser Trabeculoplasty in Open Angle Glaucoma

Glaucoma Clinical Trial

Official title:

Direct Application of Selective Laser Trabeculoplasty in Open Angle Glaucoma . Single Site Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01383525
• Other study ID #: SHEBA-11-8414
• Status: Completed
• Phase: N/A
• Start date: July 2011
• Est. completion date: November 2019

Study information

• Verified date: February 2020
• Source: Belkin Laser Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle

Intervention

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.

Locations

Country	Name	City	State
Israel	The Sam Rothberg Glaucoma Center Goldschleger Eye Institute Sheba meical Center	Ramat-Gan

Sponsors (2)

Lead Sponsor	Collaborator
Belkin Laser Ltd.	Horizon 2020 - European Commission

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of medications	Number of medications after treatment, as compared to before treatment.	6 months
Other	Physician perception of the usability of the system.	Physician perception of the usability of the system.	1 month
Primary	Reduction of Intra-Ocular pressure	Percentage reduction of intra-ocular pressure following the non contact selective laser trabeculoplasty treatment	1,3 month
Secondary	Reduction of Intra-Ocular pressure	Percentage reduction of intra-ocular pressure following the non contact selective laser trabeculoplasty treatment	6 months