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

Primary Purpose

Primary Open Angle Glaucoma

Status
Unknown status
Phase
Early Phase 1
Locations
Singapore
Study Type
Interventional
Intervention
EXTERNAL MICROPULSE DIODE LASER TRANSSCLERAL TRABECULOPLASTY
Sponsored by
National University Hospital, Singapore
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Open Angle Glaucoma focused on measuring Primary Open Angle Glaucoma

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National University HospitalRecruiting

Outcomes

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

Full Information

First Posted
March 5, 2007
Last Updated
May 13, 2008
Sponsor
National University Hospital, Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT00443664
Brief Title
External Micropulse Diode Laser Transscleral Trabeculoplasty (EMDLT) for Severe Open Angle Glaucoma
Acronym
EMDLT
Official Title
External Micropulse Diode Laser Transscleral Trabeculoplasty(EMDLT) For Severe Open Angle Glaucoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Unknown status
Study Start Date
June 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
National University Hospital, Singapore

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open Angle Glaucoma
Keywords
Primary Open Angle Glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
EXTERNAL MICROPULSE DIODE LASER TRANSSCLERAL TRABECULOPLASTY
Primary Outcome Measure Information:
Title
The amount of pressure lowering after EXTERNAL MICROPULSE DIODE LASER TRANSSCLERAL TRABECULOPLASTY (EMDLT) treatment.
Secondary Outcome Measure Information:
Title
Study of safety of EXTERNAL MICROPULSE DIODE LASER TRANSSCLERAL TRABECULOPLASTY (EMDLT) treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paul TK Chew, MBBS,MMedoph
Phone
+65-6772-5317
Email
ophchewp@nus.edu.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul TK Chew, MBBS,MMedOph
Organizational Affiliation
National University Hospital, Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul TK Chew, MBBS,MMedoph
Phone
+65-6772-5317
Email
ophchewp@nus.edu.sg
First Name & Middle Initial & Last Name & Degree
Paul TK Chew, MBBS,MMedoph
First Name & Middle Initial & Last Name & Degree
Jin F Cheng, MBCHB, MMED
First Name & Middle Initial & Last Name & Degree
Grace Dizon, MBBS

12. IPD Sharing Statement

Citations:
PubMed Identifier
2255512
Citation
The Glaucoma Laser Trial (GLT). 2. Results of argon laser trabeculoplasty versus topical medicines. The Glaucoma Laser Trial Research Group. Ophthalmology. 1990 Nov;97(11):1403-13.
Results Reference
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PubMed Identifier
11297496
Citation
Kramer TR, Noecker RJ. Comparison of the morphologic changes after selective laser trabeculoplasty and argon laser trabeculoplasty in human eye bank eyes. Ophthalmology. 2001 Apr;108(4):773-9. doi: 10.1016/s0161-6420(00)00660-6.
Results Reference
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Citation
Ho CL Micropulse Diode Trans-scleral Cyclophotocoagulation Asian Journal of ophth. 2001 supplement. vol 3,no 3,4
Results Reference
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Citation
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.
Results Reference
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External Micropulse Diode Laser Transscleral Trabeculoplasty (EMDLT) for Severe Open Angle Glaucoma

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