NCT01788319

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2013

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 11, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

June 23, 2015

Status Verified

February 1, 2013

Enrollment Period

1.8 years

First QC Date

February 1, 2013

Last Update Submit

June 22, 2015

Conditions

Open Angle Glaucoma

Keywords

laser trabeculoplastyglaucoma

Outcome Measures

Primary Outcomes (1)

  • to compare the intraocular pressure reduction with the micropulse laser trabeculoplasty (532nm) versus the conventional laser trabeculoplasty (532nm)

    one year of follow-up

Secondary Outcomes (1)

  • Secondary the complication rate between the two techniques will be compared

    one year of follow up

Study Arms (1)

lasertrabeculoplasty

EXPERIMENTAL
Procedure: lasertrabeculoplasty

Interventions

lasertrabeculoplastyPROCEDURE
Also known as: Conventional (532nm)
lasertrabeculoplasty

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • history of ocular trauma
  • intraocular surgery (except for phaco)
  • pigment dispersion and exfoliation glaucoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, UZLeuven

Leuven, Belgium

Location

MeSH Terms

Conditions

Glaucoma, Open-AngleGlaucoma

Interventions

Congresses as Topic

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

OrganizationsHealth Care Economics and Organizations

Study Officials

  • Evelien Vandewalle, MD, PhD

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2013

First Posted

February 11, 2013

Study Start

February 1, 2013

Primary Completion

December 1, 2014

Study Completion

June 1, 2015

Last Updated

June 23, 2015

Record last verified: 2013-02

Locations

BE(1)