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

This study is not yet open for participant recruitment.
Verified February 2013 by Universitaire Ziekenhuizen Leuven
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01788319
First received: February 1, 2013
Last updated: February 7, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Open Angle Glaucoma
Procedure: lasertrabeculoplasty

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Micropulse Laser Trabeculoplasty (532nm) Versus Conventional Laser Trabeculoplasty (532nm) in Open Angle Glaucoma Patients

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Secondary the complication rate between the two techniques will be compared [ Time Frame: one year of follow up ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: February 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: lasertrabeculoplasty Procedure: lasertrabeculoplasty
Other Name: Conventional (532nm)

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01788319

Contacts
Contact: University Hospitals Leuven +32 16 332372

Locations
Belgium
Department of Ophthalmology, UZLeuven
Leuven, Belgium
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Evelien Vandewalle, MD, PhD Universitaire Ziekenhuizen Leuven
  More Information

No publications provided

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01788319     History of Changes
Other Study ID Numbers: S55194
Study First Received: February 1, 2013
Last Updated: February 7, 2013
Health Authority: Belgium: Ethics Committee

Keywords provided by Universitaire Ziekenhuizen Leuven:
laser trabeculoplasty
glaucoma

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on April 20, 2014