NCT01342406

Brief Summary

This study will compare aqueous humor dynamics in adults with primary open angle glaucoma that receive Selective Laser Trabeculoplasty (SLT).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2010

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 27, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

September 6, 2023

Status Verified

August 1, 2023

Enrollment Period

3.2 years

First QC Date

April 25, 2011

Last Update Submit

August 30, 2023

Conditions

Open Angle Glaucoma

Outcome Measures

Primary Outcomes (1)

  • Changes in intraocular pressure (IOP) after Selective Laser Trabeculoplasty (SLT) and changes in outflow facility

    This study will compare aqueous humor dynamics (intraocular pressure) in adults with primary open angle glaucoma that receive Selective Laser Trabeculoplasty (SLT).

    3 years

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects with open angle glaucoma

You may qualify if:

  • years of age and older
  • Eye consideration for SLT (intraocular pressure above target with current medications, intolerance/allergy to topical medications, patient preference as primary treatment)
  • Open angles on gonioscopy

You may not qualify if:

  • Any previous surgical or laser procedures
  • Secondary glaucoma including pigmentary, exfoliative, uveitic, and traumatic glaucomas
  • Corneal opacities interfering with adequate fluorophotometry
  • Any active ocular infection within the past 2 months
  • Any corneal pathology increasing the likelihood of corneal abrasions
  • Inability to safely washout medications prior to laser treatment
  • Allergies to fluorescein, timolol, dorzolamide, or sulfa
  • Excessive (3+) trabecular meshwork pigmentation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Nebraska Medical Center, Department of Ophthalmology

Omaha, Nebraska, 68198-5540, United States

Location

University of Nebraska Medical Center, Department of Ophthalmology

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Study Officials

  • Vikas Gulati, MD

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 25, 2011

First Posted

April 27, 2011

Study Start

September 1, 2010

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

September 6, 2023

Record last verified: 2023-08

Locations

US(2)