NCT00429819

Brief Summary

We hypothesize that glaucoma patients demonstrate an impaired retinal vascular response to the flicker stimulus, and that this disturbance is predictive of the progression of glaucomatous damage. The response of a major temporal superior and inferior retinal artery and vein to a 60 seconds 12.5 Hz flicker light stimulation in 50 glaucoma patients, 50 ocular hypertensives and 50 controls (using the Retinal Vessel Analyzer) and to investigate how intraocular pressure relates to neurovascular coupling. In addition, 50 glaucoma patients and 50 ocular hypertension patients will be followed for 3 years for functional (visual field, automated perimetry with Octopus device) and morphological (retinal nerve fiber layer thickness, Optical Coherence Tomography Stratus (OCT) device) glaucomatous damage progression, in order to test the predictive power of the retinal vascular flicker response for glaucoma progression.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2006

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

December 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 1, 2007

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 16, 2014

Status Verified

December 1, 2014

Enrollment Period

7.5 years

First QC Date

January 31, 2007

Last Update Submit

December 15, 2014

Conditions

GlaucomaOcular Hypertension

Outcome Measures

Primary Outcomes (1)

  • Prognostic value of Flicker Response in glaucoma patients and ocular hypertension (OHT)

    up to 3 years

Eligibility Criteria

Age40 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

glaucoma patients ocular hypertension

You may qualify if:

  • Glaucoma
  • Ocular hypertension

You may not qualify if:

  • PEX or pigment dispersion syndrome
  • A history of an acute glaucoma attack
  • Chamber angle dysgenesia
  • Any form of secondary glaucoma
  • Diabetes
  • High levels of blood lipids
  • Systemic or ocular circulatory diseases
  • Medication, drugs, alcohol, smoking
  • Systolic blood pressure above 145 mmHg or a diastolic above 95 mmHg
  • Visual acuity worse than 20/25
  • High ametropia (spherical equivalent \< -5 diopters or \> +3 diopters)
  • Astigmatism above 2 diopters
  • Significant cataract filtering procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Eye Clinic

Basel, Canton of Basel-City, 4031, Switzerland

Location

MeSH Terms

Conditions

GlaucomaOcular Hypertension

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Selim Orgül, MD

    University Eye Clinic Basel

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

January 31, 2007

First Posted

February 1, 2007

Study Start

December 1, 2006

Primary Completion

June 1, 2014

Study Completion

December 1, 2014

Last Updated

December 16, 2014

Record last verified: 2014-12

Locations

CH(1)