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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00443664
Other study ID # DSRB-A/06/165
Secondary ID
Status Recruiting
Phase Phase 0
First received March 5, 2007
Last updated May 13, 2008
Start date June 2006
Est. completion date December 2008

Study information

Verified date May 2008
Source National University Hospital, Singapore
Contact Paul TK Chew, MBBS,MMedoph
Phone +65-6772-5317
Email ophchewp@nus.edu.sg
Is FDA regulated No
Health authority Singapore: Domain Specific Review Boards
Study type Interventional

Clinical Trial Summary

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


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


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 2008
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 21 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Device:
EXTERNAL MICROPULSE DIODE LASER TRANSSCLERAL TRABECULOPLASTY


Locations

Country Name City State
Singapore National University Hospital Singapore

Sponsors (1)

Lead Sponsor Collaborator
National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

References & Publications (4)

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.

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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The amount of pressure lowering after EXTERNAL MICROPULSE DIODE LASER TRANSSCLERAL TRABECULOPLASTY (EMDLT) treatment.
Secondary Study of safety of EXTERNAL MICROPULSE DIODE LASER TRANSSCLERAL TRABECULOPLASTY (EMDLT) treatment
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