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Effects of Selective Laser Trabeculoplasty (SLT)

This study has been terminated.
(PI left the University)
Sponsor:
Information provided by (Responsible Party):
University of Kentucky
ClinicalTrials.gov Identifier:
NCT00986141
First received: September 25, 2009
Last updated: April 23, 2013
Last verified: April 2013
History of Changes
  Purpose

Primary objective is to evaluate the effect of selective laser trabeculoplasty (SLT) on the diurnal intraocular pressure variation in open-angle glaucoma patients (OAG).


Condition Intervention Phase
Glaucoma
 Procedure: Surgery
Procedure: Selective Laser Trabeculoplasty
 Phase 4

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Effect of Selective Laser Trabeculoplasty (SLT) on Diurnal Intraocular Pressure in Open-Angle Glaucoma Patients on Medical Treatment

Resource links provided by NLM:

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • To evaluate the effect of selective laser trabeculoplasty on the diurnal intraocular pressure variation in OAG patients. [ Time Frame: Three years ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: May 2009
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
laser trabeculoplasty
Subjects with POAG and on medical treatment who are undergoing SLT
 Procedure: Surgery
Selective Laser Trabeculoplasty for glaucoma
Other Name: Selective Laser Trabeculoplasty
Procedure: Selective Laser Trabeculoplasty
Glaucoma Treatment
Other Name: SLT
Surgery
Glaucoma laser 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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00986141

Locations
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40506
Sponsors and Collaborators
University of Kentucky
Investigators
Study Director: Deborah Davis, Assoc V Chair Univ of KY Reseach Foundation
  More Information

No publications provided

Responsible Party: University of Kentucky
ClinicalTrials.gov Identifier: NCT00986141     History of Changes
Other Study ID Numbers: IRB 09-0315
Study First Received: September 25, 2009
Last Updated: April 23, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on May 19, 2013