The Role of Steroids Following Selective Laser Trabeculop... | NCT00406042

Studies
The Role of Steroids Following Selective Laser Trabeculoplasty

NCT00406042

Sponsor

West Virginia University

Status

Completed

Last Update Posted

Mar 29, 2007Estimated

Enrollment

Phase

Not Applicable

Conditions

Glaucoma

Interventions

prednisolone acetate 1%

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2005

Primary Completion Date

Not provided

Completion Date

Jun 2006Actual

First Submitted Date

Nov 29, 2006

First Submission Date that Met QC Criteria

Nov 29, 2006

First Posted Date

Dec 4, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 28, 2007

Last Update Posted Date

Mar 29, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
prednisolone acetate 1%	Drug

Measure	Description	Time Frame
Intraocular pressure reduction

Measure	Description	Time Frame
Anterior chamber inflammation

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tony Realini, MD	West Virginia University Eye Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
West Virginia University Eye Institute		Morgantown	West Virginia	26505	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20128578	Derived	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.

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases