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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2008 by National University Hospital, Singapore.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00443664
First Posted: March 6, 2007
Last Update Posted: May 15, 2008
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.
Information provided by:
National University Hospital, Singapore
  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 Early Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Ho CL Micropulse Diode Trans-scleral Cyclophotocoagulation Asian Journal of ophth. 2001 supplement. vol 3,no 3,4
Ingvoldstad DD, Krishna R, Willoughby L. MicroPulse Diode Laser Trabeculoplasty versus Argon Laser Trabeculoplasty in the treatment of Open angle glaucoma. Presented at ARVO 2005, Poster 123.

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
First Submitted: March 5, 2007
First Posted: March 6, 2007
Last Update Posted: May 15, 2008
Last Verified: May 2008

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

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