External Micropulse Diode Laser Transscleral Trabeculoplasty (EMDLT) for Severe Open Angle Glaucoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by National University Hospital, Singapore.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT00443664
First received: March 5, 2007
Last updated: May 13, 2008
Last verified: May 2008
  Purpose

To prove that external contact micropulse diode laser trabeculoplasty (EMDLT) can significantly lower intraocular pressure in cases of advanced open angle glaucoma.


Condition Intervention Phase
Primary Open Angle Glaucoma
Device: EXTERNAL MICROPULSE DIODE LASER TRANSSCLERAL TRABECULOPLASTY
Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: External Micropulse Diode Laser Transscleral Trabeculoplasty(EMDLT) For Severe Open Angle Glaucoma

Resource links provided by NLM:


Further study details as provided by National University Hospital, Singapore:

Primary Outcome Measures:
  • The amount of pressure lowering after EXTERNAL MICROPULSE DIODE LASER TRANSSCLERAL TRABECULOPLASTY (EMDLT) treatment.

Secondary Outcome Measures:
  • Study of safety of EXTERNAL MICROPULSE DIODE LASER TRANSSCLERAL TRABECULOPLASTY (EMDLT) treatment

Estimated Enrollment: 30
Study Start Date: June 2006
Estimated Study Completion Date: December 2008
Detailed Description:

Micropulse diode laser trabeculoplasty applied through a gonioscopy len has been shown to be effective in lower the pressure for patients with primary open angle glaucoma (POAG). We believe that applied externally, the contact diode micropulse laser will be effective in lowering intraocular pressure for patients with advance open angle glaucoma with minimal side effects

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • • Diagnosis of Primary Open Angle Glaucoma

    • Advanced glaucoma with intraocular pressure higher than 21mmHg on one or more topical medications (for at least 2 months)
    • Visual acuity worse than 6/6
    • Age more than 21 years
    • Poor candidate for additional filtration surgery

Exclusion Criteria:

  • • Age less than 21 years

    • Any eye surgery within 2 months of enrolment
    • Any patient with rubeosis
    • Unable to give informed consent
  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: NCT00443664

Contacts
Contact: Paul TK Chew, MBBS,MMedoph +65-6772-5317 ophchewp@nus.edu.sg

Locations
Singapore
National University Hospital Recruiting
Singapore, Singapore, 119074
Contact: Paul TK Chew, MBBS,MMedoph    +65-6772-5317    ophchewp@nus.edu.sg   
Principal Investigator: Paul TK Chew, MBBS,MMedoph         
Sub-Investigator: Jin F Cheng, MBCHB, MMED         
Sub-Investigator: Grace Dizon, MBBS         
Sponsors and Collaborators
National University Hospital, Singapore
Investigators
Principal Investigator: Paul TK Chew, MBBS,MMedOph National University Hospital, Singapore
  More Information

Publications:
Responsible Party: Paul TK Chew, MBBS,MMedoph, National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT00443664     History of Changes
Other Study ID Numbers: DSRB-A/06/165
Study First Received: March 5, 2007
Last Updated: May 13, 2008
Health Authority: Singapore: Domain Specific Review Boards

Keywords provided by National University Hospital, Singapore:
Primary Open Angle Glaucoma

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

ClinicalTrials.gov processed this record on October 19, 2014