Direct Application of Selective Laser Trabeculoplasty in Open Angle Glaucoma

NCT01383525 | Completed

• 1 other identifier: SHEBA-11-8414
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma

Keywords

SLT, LTP, DSLT; non contact; Trabeculoplasty; Laser; intraocular pressure

Outcome Measures

Primary Outcomes (1)

• Reduction of Intra-Ocular pressure

  Percentage reduction of intra-ocular pressure following the non contact selective laser trabeculoplasty treatment

  1,3 month

Secondary Outcomes (1)

• Reduction of Intra-Ocular pressure

  6 months

Other Outcomes (2)

• Number of medications

  6 months

• Physician perception of the usability of the system.

  1 month

Study Arms (1)

Direct Selective Trabeculoplasty

EXPERIMENTAL

Treatment by an Direct Selective Trabeculoplasty device

Device: Direct Selective Trabeculoplasty device

Interventions

Direct Selective Trabeculoplasty device DEVICE

Patients will be treated with a Direct Selective Trabeculoplasty (DLTP) laser. Placement of the spots is on the sclera around the limbus.

Direct Selective Trabeculoplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• BelkinVision: lead
• Horizon 2020 - European Commission: collaborator

Study Sites (1)

The Sam Rothberg Glaucoma Center Goldschleger Eye Institute Sheba meical Center

Ramat Gan, 52621, Israel

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Alon Skaat, MD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking for treatment. The follow-up and primary endpoint assessment, intra-ocular pressure (IOP) measurement, is performed by masked ophthalmologist.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2011
• First Posted: June 28, 2011
• Study Start: July 1, 2011
• Primary Completion: August 1, 2019
• Study Completion: November 1, 2019
• Last Updated: February 26, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)