- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00986141
Effects of Selective Laser Trabeculoplasty (SLT)
April 23, 2013 updated by: University of Kentucky
Effect of Selective Laser Trabeculoplasty (SLT) on Diurnal Intraocular Pressure in Open-Angle Glaucoma Patients on Medical Treatment
Primary objective is to evaluate the effect of selective laser trabeculoplasty (SLT) on the diurnal intraocular pressure variation in open-angle glaucoma patients (OAG).
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
This is a prospective observational study of OAG patients undergoing selective laser trabeculoplasty at the University of Kentucky Chandler Medical Center.
The patients will be recruited over 12 months.
Study will include 3 visits: pre-laser visit, visit for laser treatment and post-laser visit.
All visits will occur within a 3-month period.
Study Type
Observational
Enrollment (Actual)
30
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
-
-
Kentucky
-
Lexington, Kentucky, United States, 40506
- University Of Kentucky
-
-
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
40 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Thirty patients, between the ages of 40 and 80, of either gender, from all ethnic backgrounds will be recruited in this study.
Description
Inclusion Criteria:
- Subjects who have the diagnosis of open angle glaucoma
- Subjects who are able to speak and understand English and provide meaningful written informed consent,
- Subjects who are willing and able to comply with all testing and requirements defined in the protocol and willing and able to comply with all required study visits.
Exclusion Criteria:
- Subjects with previous laser treatment or intraocular surgery,
- Subjects with history of ocular inflammation and with history of previous ocular trauma.
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
laser trabeculoplasty
Subjects with POAG and on medical treatment who are undergoing SLT
|
Selective Laser Trabeculoplasty for glaucoma
Other Names:
Glaucoma Treatment
Other Names:
|
|
Surgery
Glaucoma laser treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To evaluate the effect of selective laser trabeculoplasty on the diurnal intraocular pressure variation in OAG patients.
Time Frame: Three years
|
Three years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Deborah Davis, Assoc V Chair, Univ of KY Reseach Foundation
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
May 1, 2009
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
September 25, 2009
First Submitted That Met QC Criteria
September 28, 2009
First Posted (Estimate)
September 29, 2009
Study Record Updates
Last Update Posted (Estimate)
April 24, 2013
Last Update Submitted That Met QC Criteria
April 23, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB 09-0315
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.