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

This study is currently recruiting participants.
Verified by National University Hospital, Singapore, May 2008

Sponsored by: National University Hospital, Singapore
Information provided by: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT00443664
  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

Genetics Home Reference related topics:   early-onset glaucoma   

MedlinePlus related topics:   Glaucoma   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:   External Micropulse Diode Laser Transscleral Trabeculoplasty(EMDLT) For Severe Open Angle Glaucoma

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

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

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

Study placed in the following topic categories:
Glaucoma
Eye Diseases
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension

ClinicalTrials.gov processed this record on October 07, 2008




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