External Micropulse Diode Laser Transscleral Trabeculopla... | NCT00443664

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

NCT00443664

Sponsor

National University Hospital, Singapore

Status

Unknown status

Last Update Posted

May 15, 2008Estimated

Enrollment

30Estimated

Phase

Early Phase 1

Conditions

Primary Open Angle Glaucoma

Interventions

EXTERNAL MICROPULSE DIODE LASER TRANSSCLERAL TRABECULOPLASTY

Countries

Singapore

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2006

Primary Completion Date

Not provided

Completion Date

Dec 2008Estimated

First Submitted Date

Mar 5, 2007

First Submission Date that Met QC Criteria

Mar 5, 2007

First Posted Date

Mar 6, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 13, 2008

Last Update Posted Date

May 15, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Name	Type	Description	Arm Group Labels	Other Names
EXTERNAL MICROPULSE DIODE LASER TRANSSCLERAL TRABECULOPLASTY	Device

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Study of safety of EXTERNAL MICROPULSE DIODE LASER TRANSSCLERAL TRABECULOPLASTY (EMDLT) treatment

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Paul TK Chew, MBBS,MMedoph	Contact	+65-6772-5317		ophchewp@nus.edu.sg

Overall Officials

Name	Affiliation	Role
Paul TK Chew, MBBS,MMedOph	National University Hospital, Singapore	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National University Hospital	Recruiting	Singapore		119074	Singapore

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
2255512	Background	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.
11297496	Background	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.

ID	Term
D005901	Glaucoma
D009798	Ocular Hypertension
D005128	Eye Diseases