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

This study is not yet open for participant recruitment. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014