search
Back to results

The Role of Steroids Following Selective Laser Trabeculoplasty

Primary Purpose

Glaucoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
prednisolone acetate 1%
Sponsored by
West Virginia University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring glaucoma, trabeculoplasty, steroids

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • glaucoma or ocular hypertension
  • need for bilateral SLT

Exclusion Criteria:

  • eye disease precluding accurate IOP measurement
  • contraindication to topical prednisolone acetate

Sites / Locations

  • West Virginia University Eye Institute

Outcomes

Primary Outcome Measures

Intraocular pressure reduction

Secondary Outcome Measures

Anterior chamber inflammation

Full Information

First Posted
November 29, 2006
Last Updated
March 28, 2007
Sponsor
West Virginia University
search

1. Study Identification

Unique Protocol Identification Number
NCT00406042
Brief Title
The Role of Steroids Following Selective Laser Trabeculoplasty
Official Title
The Role of Topical Prednisolone Acetate Following Selective Laser Trabeculoplasty
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
West Virginia University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate whether or not using topical steroids after selective laser trabeculoplasty affects intraocular pressure outcomes.
Detailed Description
Subjects undergoing bilateral SLT will be randomly assigned to use prednisolone acetate 1% in one eye four times daily with no treatment in the fellow eye, for one week following SLT. Examinations will occur at baseline, and one week, one month and three months after SLT. IOP and anterior chamber inflammation will be noted at each visit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
glaucoma, trabeculoplasty, steroids

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
25 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
prednisolone acetate 1%
Primary Outcome Measure Information:
Title
Intraocular pressure reduction
Secondary Outcome Measure Information:
Title
Anterior chamber inflammation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: glaucoma or ocular hypertension need for bilateral SLT Exclusion Criteria: eye disease precluding accurate IOP measurement contraindication to topical prednisolone acetate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tony Realini, MD
Organizational Affiliation
West Virginia University Eye Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
West Virginia University Eye Institute
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26505
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20128578
Citation
Realini T, Charlton J, Hettlinger M. The impact of anti-inflammatory therapy on intraocular pressure reduction following selective laser trabeculoplasty. Ophthalmic Surg Lasers Imaging. 2010 Jan-Feb;41(1):100-3. doi: 10.3928/15428877-20091230-18.
Results Reference
derived

Learn more about this trial

The Role of Steroids Following Selective Laser Trabeculoplasty

We'll reach out to this number within 24 hrs