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NCT01788319 Clinical Trial

Micropulse Laser Trabeculoplasty (532nm) Versus Conventional Laser Trabeculoplasty (532nm)

Open Angle Glaucoma Clinical Trial

Official title:
Micropulse Laser Trabeculoplasty (532nm) Versus Conventional Laser Trabeculoplasty (532nm) in Open Angle Glaucoma Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01788319
Other study ID # S55194
Secondary ID
Status Completed
Phase N/A
First received February 1, 2013
Last updated June 22, 2015
Start date February 2013
Est. completion date June 2015

Study information
Verified date February 2013
Source Universitaire Ziekenhuizen Leuven
Contact n/a
Is FDA regulated No
Health authority Belgium: Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date June 2015
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility 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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• lasertrabeculoplasty

Locations
Country Name City State
Belgium Department of Ophthalmology, UZLeuven Leuven

Sponsors (1)
Lead Sponsor Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary to compare the intraocular pressure reduction with the micropulse laser trabeculoplasty (532nm) versus the conventional laser trabeculoplasty (532nm) one year of follow-up Yes
Secondary Secondary the complication rate between the two techniques will be compared one year of follow up Yes
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