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

Tracking Information

First Received Date ^ICMJE

March 5, 2007

Last Updated Date

May 13, 2008

Start Date ^ICMJE

June 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

The amount of pressure lowering after EXTERNAL MICROPULSE DIODE LASER TRANSSCLERAL TRABECULOPLASTY (EMDLT) treatment.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00443664 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Study of safety of EXTERNAL MICROPULSE DIODE LASER TRANSSCLERAL TRABECULOPLASTY (EMDLT) treatment

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Study Phase

Phase 0

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Primary Open Angle Glaucoma

Intervention ^ICMJE

Device: EXTERNAL MICROPULSE DIODE LASER TRANSSCLERAL TRABECULOPLASTY

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2008

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

21 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Paul TK Chew, MBBS,MMedoph

+65-6772-5317

ophchewp@nus.edu.sg

Location Countries ^ICMJE

Singapore

Administrative Information

NCT ID ^ICMJE

NCT00443664

Responsible Party

Paul TK Chew, MBBS,MMedoph, National University Hospital, Singapore

Study ID Numbers ^ICMJE

DSRB-A/06/165

Study Sponsor ^ICMJE

National University Hospital, Singapore

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Paul TK Chew, MBBS,MMedOph

National University Hospital, Singapore

Information Provided By

National University Hospital, Singapore

Verification Date

May 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP