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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01383525
First Posted: June 28, 2011
Last Update Posted: August 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Belkin Laser Ltd.
Information provided by (Responsible Party):
Sheba Medical Center
June 22, 2011
June 28, 2011
August 11, 2017
July 2011
March 2018   (Final data collection date for primary outcome measure)
Reduction of Intra-Ocular pressure [ Time Frame: 1,3 month ]
Percentage reduction of intra-ocular pressure following the non contact selective laser trabeculoplasty treatment
Reduction of Intra-Ocular pressure [ Time Frame: 3 months ]
Reduction of intra-ocular pressure following the non contact selective laser trabeculoplasty treatment
Complete list of historical versions of study NCT01383525 on ClinicalTrials.gov Archive Site
Reduction of Intra-Ocular pressure [ Time Frame: 6 months ]
Percentage reduction of intra-ocular pressure following the non contact selective laser trabeculoplasty treatment
Not Provided
  • 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.
Not Provided
 
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.

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.

Interventional
Not Provided
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
Glaucoma
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.
Experimental: Direct Selective Trabeculoplasty
Treatment by an Automated Direct Selective Trabeculoplasty device
Intervention: Device: Automated Direct Selective Trabeculoplasty device
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
April 2018
March 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT01383525
SHEBA-11-8414-MG-CTIL
No
Not Provided
Plan to Share IPD: Undecided
Sheba Medical Center
Sheba Medical Center
Belkin Laser Ltd.
Principal Investigator: Alon Skaat, MD Sheba Medical Center
Sheba Medical Center
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP