Back to resultsMicropulse Laser Trabeculoplasty (532nm) Versus Conventional Laser Trabeculoplasty (532nm)
Primary Purpose
Open Angle Glaucoma
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
lasertrabeculoplasty
Sponsored by
About this trial
This is an interventional treatment trial for Open Angle Glaucoma focused on measuring laser trabeculoplasty, glaucoma
Eligibility Criteria
Inclusion Criteria:
- individuals over 18 years old
- willing to sign an informed consent and able to comply the requirements of the study
- having no other ocular diseases besides glaucoma
Exclusion Criteria:
- history of ocular trauma
- intraocular surgery (except for phaco)
- pigment dispersion and exfoliation glaucoma
Sites / Locations
- Department of Ophthalmology, UZLeuven
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
lasertrabeculoplasty
Arm Description
Outcomes
Primary Outcome Measures
to compare the intraocular pressure reduction with the micropulse laser trabeculoplasty (532nm) versus the conventional laser trabeculoplasty (532nm)
Secondary Outcome Measures
Secondary the complication rate between the two techniques will be compared
Full Information
NCT ID
NCT01788319
First Posted
February 1, 2013
Last Updated
June 22, 2015
Sponsor
Universitaire Ziekenhuizen KU Leuven
1. Study Identification
Unique Protocol Identification Number
NCT01788319
Brief Title
Micropulse Laser Trabeculoplasty (532nm) Versus Conventional Laser Trabeculoplasty (532nm)
Official Title
Micropulse Laser Trabeculoplasty (532nm) Versus Conventional Laser Trabeculoplasty (532nm) in Open Angle Glaucoma Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will investigate if micropulse laser trabeculoplasty (532nm) is as effecttive as or better than the conventional laser trabeculoplasty (532nm), it might be a new treatment strategy for glaucoma patients. It is done with a laser device that can also be used for many other ophthalmic applications, thus reducing the economic burden of treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open Angle Glaucoma
Keywords
laser trabeculoplasty, glaucoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
lasertrabeculoplasty
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
lasertrabeculoplasty
Other Intervention Name(s)
Conventional (532nm)
Primary Outcome Measure Information:
Title
to compare the intraocular pressure reduction with the micropulse laser trabeculoplasty (532nm) versus the conventional laser trabeculoplasty (532nm)
Time Frame
one year of follow-up
Secondary Outcome Measure Information:
Title
Secondary the complication rate between the two techniques will be compared
Time Frame
one year of follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
individuals over 18 years old
willing to sign an informed consent and able to comply the requirements of the study
having no other ocular diseases besides glaucoma
Exclusion Criteria:
history of ocular trauma
intraocular surgery (except for phaco)
pigment dispersion and exfoliation glaucoma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evelien Vandewalle, MD, PhD
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Ophthalmology, UZLeuven
City
Leuven
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Micropulse Laser Trabeculoplasty (532nm) Versus Conventional Laser Trabeculoplasty (532nm)
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