Direct Application of Selective Laser Trabeculoplasty Using the "DIO-DENT 10" in Open Angle Glaucoma (SLT)

This study is currently recruiting participants.
Verified June 2012 by Sheba Medical Center
Sponsor:
Information provided by (Responsible Party):
Dr. Modi Goldenfeld, Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01383525
First received: June 22, 2011
Last updated: June 10, 2012
Last verified: June 2012
  Purpose

The trial objectives are to establish the safety & efficacy of using the "DIO-DENT 10" DENTAL DIODE LASER SYSTEM , a TSLTP laser (790 nanometers) to perform laser trabeculoplasty (TSLTP) to reduce IOP in patients with open angle glaucoma. (Including Pigmentary & Exfoliative Glaucoma) that have poorly controlled IOP.in a Non-Contact mode


Condition Intervention
Glaucoma
Device: Direct application of Selective Laser Trabeculoplasty
Device: Direct application of SLT in Open Angle Glaucoma

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Direct Application of Selective Laser Trabeculoplasty,Using the "DIO-DENT 10" DENTAL DIODE LASER SYSTEM 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: 3 months ] [ Designated as safety issue: Yes ]
    Reduction of intra-ocular pressure following the non contact selective laser trabeculoplasty treatment


Estimated Enrollment: 20
Study Start Date: July 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SLT
Uncontrolled open angle glaucoma patients who are eligible to be treated with selective laser trabeculoplasty
Device: Direct application of Selective Laser Trabeculoplasty
Direct application of SLT using "DIO-DENT 10" DENTAL DIODE LASER SYSTEM to the conjunctiva over the TM
Other Names:
  • "DIO-DENT 10" DENTAL DIODE LASER SYSTEM
  • 510(k)NumberK 03 181 4
  • SLT
  • non contact
Device: Direct application of SLT in Open Angle Glaucoma
Direct application of Selective Laser Trabeculoplasty in Open Angle Glaucoma
Other Names:
  • Direct
  • Selective Laser Trabeculoplasty
  • Open Angle Glaucoma

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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 3-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 TSLTP.
  • Having concurrent treatment with systemic steroids.
  • Patient is under 18 years old
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01383525

Locations
Israel
The Sam Rothberg Glaucoma Center Goldschleger Eye Institute Sheba meical Center Recruiting
Tel Hashomer Ramat-Gan, Israel, 52621
Contact: Mordechai Goldenfeld, MD    972353023046    modigold@goldenfeld.co.il   
Contact: Michael Belkin, MD    9723-5302956    belkin@netvision.net.il   
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Mordechai Goldenfeld, MD Sheba Medical Center
Study Chair: Michael Belkin, MD Tel Aviv University
  More Information

No publications provided

Responsible Party: Dr. Modi Goldenfeld, M.D., 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: June 10, 2012
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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

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

ClinicalTrials.gov processed this record on April 17, 2014