NCT00986141

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 29, 2009

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

April 24, 2013

Status Verified

April 1, 2013

Enrollment Period

3.6 years

First QC Date

September 25, 2009

Last Update Submit

April 23, 2013

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

  • To evaluate the effect of selective laser trabeculoplasty on the diurnal intraocular pressure variation in OAG patients.

    Three years

Study Arms (2)

laser trabeculoplasty

Subjects with POAG and on medical treatment who are undergoing SLT

Procedure: SurgeryProcedure: Selective Laser Trabeculoplasty

Surgery

Glaucoma laser treatment

Interventions

SurgeryPROCEDURE

Selective Laser Trabeculoplasty for glaucoma

Also known as: Selective Laser Trabeculoplasty
laser trabeculoplasty
Selective Laser TrabeculoplastyPROCEDURE

Glaucoma Treatment

Also known as: SLT
laser trabeculoplasty

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Subjects with previous laser treatment or intraocular surgery,
  • Subjects with history of ocular inflammation and with history of previous ocular trauma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Deborah Davis, Assoc V Chair

    Univ of KY Reseach Foundation

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2009

First Posted

September 29, 2009

Study Start

May 1, 2009

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

April 24, 2013

Record last verified: 2013-04

Locations

US(1)