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

First Received: March 5, 2007 Last Updated: May 13, 2008 History of Changes

Sponsor:	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

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

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

U.S. FDA Resources

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:

[No authors listed] 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.

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.

Ho CL Micropulse Diode Trans-scleral Cyclophotocoagulation Asian Journal of ophth. 2001 supplement. vol 3,no 3,4

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

Keywords provided by National University Hospital, Singapore:

Primary Open Angle Glaucoma

Additional relevant MeSH terms:

Glaucoma
Eye Diseases
Glaucoma, Open-Angle
Ocular Hypertension

ClinicalTrials.gov processed this record on November 22, 2009