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Steroids After Laser Trabeculoplasty for Glaucoma (SALT)

Primary Purpose

Glaucoma

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Prednisolone 1%
Ketorolac
Artificial Tears
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring Glaucoma, Trabeculoplasty, Selective laser trabeculoplasty, Intraocular pressure

Eligibility Criteria

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

Inclusion Criteria:

  • clinical diagnosis of glaucoma
  • clinician has determined that SLT laser is indicated
  • IOP currently >18 and was ever >21 in the past (e.g. prior to treatment)

Exclusion Criteria:

  • prior history of uveitis
  • prior glaucoma surgery including glaucoma laser surgery
  • pregnant or 3 months post-partum

Sites / Locations

  • Bascom Palmer Eye Institute
  • University of Pittsburgh Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Artificial Tears

Non-steroidal anti-inflammatory

Steroid

Arm Description

Topical artificial tears dosed 4 times per day for 4 days in treated eye after laser trabeculoplasty.

Topical ketorolac 0.5% dosed 4 times per day for 4 days in treated eye after laser trabeculoplasty.

Topical prednisolone 1% dosed 4 times per day for 4 days in treated eye after laser trabeculoplasty.

Outcomes

Primary Outcome Measures

Intraocular Pressure (IOP) Change
IOP will be measured before and at 6 and 12 weeks after intervention using Goldman tonometry.

Secondary Outcome Measures

Intraocular Inflammation
The count of patients with inflammation defined as anterior chamber cells was measured in each study arm.

Full Information

First Posted
September 21, 2009
Last Updated
July 23, 2019
Sponsor
Stanford University
Collaborators
Bascom Palmer Eye Institute, University of Pittsburgh Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00981435
Brief Title
Steroids After Laser Trabeculoplasty for Glaucoma
Acronym
SALT
Official Title
Steroids And Laser Trabeculoplasty (SALT) Trial: Effect of Anti-Inflammatory Treatment on the Efficacy of SLT
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
Bascom Palmer Eye Institute, University of Pittsburgh Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether the choice of post-operative eye drop administered after selective laser trabeculoplasty (SLT) for glaucoma affects the efficacy in lowering intraocular pressure (IOP).
Detailed Description
SLT is used to lower intraocular pressure in glaucoma, but it is not know whether the choice of eyedrops administered in the post-operative period affects SLT efficacy. Practitioners commonly use steroid drops, non-steroidal anti-inflammatory drops, or no drops at all. This is a randomized, single-center, prospective, masked clinical trial to determine whether the choice of eyedrop affects efficacy of SLT in glaucoma patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
Glaucoma, Trabeculoplasty, Selective laser trabeculoplasty, Intraocular pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Artificial Tears
Arm Type
Experimental
Arm Description
Topical artificial tears dosed 4 times per day for 4 days in treated eye after laser trabeculoplasty.
Arm Title
Non-steroidal anti-inflammatory
Arm Type
Experimental
Arm Description
Topical ketorolac 0.5% dosed 4 times per day for 4 days in treated eye after laser trabeculoplasty.
Arm Title
Steroid
Arm Type
Experimental
Arm Description
Topical prednisolone 1% dosed 4 times per day for 4 days in treated eye after laser trabeculoplasty.
Intervention Type
Drug
Intervention Name(s)
Prednisolone 1%
Other Intervention Name(s)
Pred forte
Intervention Description
Prednisolone 1% to lasered eye 4 times/day for 4.5 days
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Other Intervention Name(s)
Voltaren
Intervention Description
Ketorolac 0.5% to lasered eye 4 times/day for 4.5 days
Intervention Type
Drug
Intervention Name(s)
Artificial Tears
Other Intervention Name(s)
saline tears
Intervention Description
Artificial saline tears to lasered eye 4 times/day for 4.5 days
Primary Outcome Measure Information:
Title
Intraocular Pressure (IOP) Change
Description
IOP will be measured before and at 6 and 12 weeks after intervention using Goldman tonometry.
Time Frame
Baseline to Week 12
Secondary Outcome Measure Information:
Title
Intraocular Inflammation
Description
The count of patients with inflammation defined as anterior chamber cells was measured in each study arm.
Time Frame
Up to week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: clinical diagnosis of glaucoma clinician has determined that SLT laser is indicated IOP currently >18 and was ever >21 in the past (e.g. prior to treatment) Exclusion Criteria: prior history of uveitis prior glaucoma surgery including glaucoma laser surgery pregnant or 3 months post-partum
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey L Goldberg, MD, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bascom Palmer Eye Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD is anticipated to be shared upon publication of results.

Learn more about this trial

Steroids After Laser Trabeculoplasty for Glaucoma

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