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Direct Application of Selective Laser Trabeculoplasty in Open Angle Glaucoma (DSLT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Belkin Laser Ltd.
Information provided by (Responsible Party):
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01383525
First received: June 22, 2011
Last updated: August 9, 2017
Last verified: August 2017
  Purpose
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.

Condition Intervention
Glaucoma Device: Automated Direct Selective Trabeculoplasty device

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description:
No masking for treatment. The primary endpoint assessment- intra-ocular pressure (IOP) measurement is performed by masked ophthalmologist
Primary Purpose: Treatment
Official Title: Direct Application of Selective Laser Trabeculoplasty in Open Angle Glaucoma . Single Site Study

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Reduction of Intra-Ocular pressure [ Time Frame: 1,3 month ]
    Percentage reduction of intra-ocular pressure following the non contact selective laser trabeculoplasty treatment


Secondary Outcome Measures:
  • Reduction of Intra-Ocular pressure [ Time Frame: 6 months ]
    Percentage reduction of intra-ocular pressure following the non contact selective laser trabeculoplasty treatment


Other Outcome Measures:
  • Number of medications [ Time Frame: 6 months ]
    Number of medications after treatment, as compared to before treatment.

  • Physician perception of the usability of the system. [ Time Frame: 1 month ]
    Physician perception of the usability of the system.


Estimated Enrollment: 40
Study Start Date: July 2011
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Direct Selective Trabeculoplasty
Treatment by an Automated Direct Selective Trabeculoplasty device
Device: Automated 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.

Detailed Description:

This is a single site outpatient 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).

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 less than one-second, through the sclera.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 (DSLP)
  • Having concurrent treatment with systemic steroids.
  • Patient is under 18 years old
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01383525

Locations
Israel
The Sam Rothberg Glaucoma Center Goldschleger Eye Institute Sheba meical Center
Ramat-Gan, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
Belkin Laser Ltd.
Investigators
Principal Investigator: Alon Skaat, MD Sheba Medical Center
  More Information

Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01383525     History of Changes
Other Study ID Numbers: SHEBA-11-8414-MG-CTIL
Study First Received: June 22, 2011
Last Updated: August 9, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Sheba Medical Center:
SLT, LTP
non contact
Trabeculoplasty
Laser
intraocular pressure

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on August 18, 2017