NCT00443664

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Jun 2006

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 6, 2007

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

May 15, 2008

Status Verified

May 1, 2008

First QC Date

March 5, 2007

Last Update Submit

May 13, 2008

Conditions

Primary Open Angle Glaucoma

Keywords

Primary Open Angle Glaucoma

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

EXTERNAL MICROPULSE DIODE LASER TRANSSCLERAL TRABECULOPLASTYDEVICE

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Age less than 21 years
  • Any eye surgery within 2 months of enrolment
  • Any patient with rubeosis
  • Unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital

Singapore, 119074, Singapore

RECRUITING

Related Publications (4)

  • 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.

    PMID: 2255512BACKGROUND

  • 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.

    PMID: 11297496BACKGROUND

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

    BACKGROUND

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Study Officials

  • Paul TK Chew, MBBS,MMedOph

    National University Hospital, Singapore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul TK Chew, MBBS,MMedoph

CONTACT

+65-6772-5317ophchewp@nus.edu.sg

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 5, 2007

First Posted

March 6, 2007

Study Start

June 1, 2006

Study Completion

December 1, 2008

Last Updated

May 15, 2008

Record last verified: 2008-05

Locations

SG(1)