NCT01145911

Brief Summary

To determine the relationships between ocular hemodynamics and glaucomatous optic neuropathy progression.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
123

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

January 1, 2008

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

June 15, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 17, 2010

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2014

Completed
Last Updated

March 7, 2017

Status Verified

March 1, 2017

Enrollment Period

6.5 years

First QC Date

June 15, 2010

Last Update Submit

March 6, 2017

Conditions

Keywords

GlaucomaBlood FlowProgression

Outcome Measures

Primary Outcomes (1)

  • Ocular Blood Flow

    per visit

    various

Study Arms (1)

Glaucoma patients

Glaucoma patients

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Glaucoma patients

You may qualify if:

  • Age: 30 years or older.
  • Diagnosis: confirmed open-angle glaucoma in at least one eye:
  • glaucomatous visual field loss on Humphrey 24-2 or 10-2 perimetry
  • glaucomatous optic disc cupping
  • agreement between two baseline exams for reliability
  • Best corrected visual acuity at least 20/60 in at least one eye.
  • Prior Humphrey visual fields demonstrate acceptable reliability standards (see below).

You may not qualify if:

  • Extensive Humphrey visual field damage consisting of either a mean deviation (MD) \< -15 decibels or a clinically determined threat to fixation in both hemifields.
  • Evidence of exfoliation or pigment dispersion.
  • History of acute angle-closure or a narrow, occludable anterior chamber angle by gonioscopy.
  • History of chronic or recurrent inflammatory eye diseases (e.g., scleritis, uveitis).
  • History or signs of intraocular trauma.
  • Severe or potentially progressive retinal disease such as retinal degeneration, diabetic retinopathy, and retinal detachment.
  • Any abnormality preventing reliable applanation tonometry.
  • Current use of any ophthalmic or systemic steroid which may interfere with this investigation.
  • Cataract surgery within the past year.
  • Resting pulse \< 50 beats per minute.
  • Severe, unstable or uncontrolled cardiovascular, renal, or pulmonary disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University School of Medicine, Department of Ophthalmology

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

  • Verticchio Vercellin AC, Harris A, Oddone F, Siesky B, Eckert G, Belamkar A, Antman G, Segev F. Ocular blood flow biomarkers may predict long-term glaucoma progression. Br J Ophthalmol. 2024 Jun 20;108(7):946-950. doi: 10.1136/bjo-2022-322644.

MeSH Terms

Conditions

GlaucomaDisease Progression

Condition Hierarchy (Ancestors)

Ocular HypertensionEye DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Alon Harris, PhD

    Indiana University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 15, 2010

First Posted

June 17, 2010

Study Start

January 1, 2008

Primary Completion

July 3, 2014

Study Completion

July 3, 2014

Last Updated

March 7, 2017

Record last verified: 2017-03

Locations