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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Sheba Medical Center.
Recruitment status was  Recruiting
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
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 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 August 21, 2014