Effects of Selective Laser Trabeculoplasty | NCT00986141

Studies
Effects of Selective Laser Trabeculoplasty

NCT00986141

Sponsor

University of Kentucky

Status

Terminated

Last Update Posted

Apr 24, 2013Estimated

Enrollment

30Actual

Phase

Not provided

Conditions

Glaucoma

Interventions

Surgery
Selective Laser Trabeculoplasty

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

Apr 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

PI left the University

Expanded Access Info

Start Date

May 2009

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Sep 25, 2009

First Submission Date that Met QC Criteria

Sep 28, 2009

First Posted Date

Sep 29, 2009Estimated

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

Apr 23, 2013

Last Update Posted Date

Apr 24, 2013Estimated

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

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

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.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
laser trabeculoplasty		Subjects with POAG and on medical treatment who are undergoing SLT	Procedure: Surgery Procedure: Selective Laser Trabeculoplasty
Surgery		Glaucoma laser treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Surgery	Procedure	Selective Laser Trabeculoplasty for glaucoma	laser trabeculoplasty

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To evaluate the effect of selective laser trabeculoplasty on the diurnal intraocular pressure variation in OAG patients.		Three years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Thirty patients, between the ages of 40 and 80, of either gender, from all ethnic backgrounds will be recruited in this study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Deborah Davis, Assoc V Chair	Univ of KY Reseach Foundation	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Kentucky		Lexington	Kentucky	40506	United States

Condition Browse Module

MeSH Terms

ID	Term
D005901	Glaucoma

Ancestor Terms

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013514	Surgical Procedures, Operative

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided