- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01788319
Micropulse Laser Trabeculoplasty (532nm) Versus Conventional Laser Trabeculoplasty (532nm)
June 22, 2015 updated by: Universitaire Ziekenhuizen KU Leuven
Micropulse Laser Trabeculoplasty (532nm) Versus Conventional Laser Trabeculoplasty (532nm) in Open Angle Glaucoma Patients
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Leuven, Belgium
- Department of Ophthalmology, UZLeuven
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: lasertrabeculoplasty
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
one year of follow-up
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Secondary the complication rate between the two techniques will be compared
Time Frame: one year of follow up
|
one year of follow up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Evelien Vandewalle, MD, PhD, Universitaire Ziekenhuizen KU Leuven
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2013
Primary Completion (ACTUAL)
December 1, 2014
Study Completion (ACTUAL)
June 1, 2015
Study Registration Dates
First Submitted
February 1, 2013
First Submitted That Met QC Criteria
February 7, 2013
First Posted (ESTIMATE)
February 11, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
June 23, 2015
Last Update Submitted That Met QC Criteria
June 22, 2015
Last Verified
February 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- S55194
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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