NCT00430209

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 ocular coherence tomography (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
150

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
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

December 11, 2013

Status Verified

December 1, 2013

Enrollment Period

7 years

First QC Date

January 31, 2007

Last Update Submit

December 10, 2013

Conditions

GlaucomaOcular Hypertension

Outcome Measures

Primary Outcomes (1)

  • Response to flicker light in glaucoma

    Response to flicker light in glaucoma, ocular hypertension (OHT) and normal subjects

    up to 3 years

Eligibility Criteria

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

glaucoma patients ocular hypertensives normal controls

You may qualify if:

  • glaucoma
  • ocular hypertension

You may not qualify if:

  • highest ever measured intraocular pressure (IOP) equal or higher than 30 mmHg
  • peripapillary hemorrhage
  • any suspicion of progression
  • PEX (pseudo exfoliations syndrome) 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 145mmHg or a diastolic above 95mmHg
  • visual acuity worse than 20/25
  • high ametropia (spherical equivalent \< -5 diopters or \> +3 diopters)
  • astigmatism above 2 diopters
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Eye Clinic

Basel, Canton of Basel-City, 4031, Switzerland

Location

Related Publications (3)

  • Gugleta K, Waldmann N, Polunina A, Kochkorov A, Katamay R, Flammer J, Orgul S. Retinal neurovascular coupling in patients with glaucoma and ocular hypertension and its association with the level of glaucomatous damage. Graefes Arch Clin Exp Ophthalmol. 2013 Jun;251(6):1577-85. doi: 10.1007/s00417-013-2276-9. Epub 2013 Feb 19.

    PMID: 23417339DERIVED

  • Gugleta K, Kochkorov A, Waldmann N, Polunina A, Katamay R, Flammer J, Orgul S. Dynamics of retinal vessel response to flicker light in glaucoma patients and ocular hypertensives. Graefes Arch Clin Exp Ophthalmol. 2012 Apr;250(4):589-94. doi: 10.1007/s00417-011-1842-2. Epub 2011 Oct 19.

    PMID: 22008947DERIVED

  • Portmann N, Gugleta K, Kochkorov A, Polunina A, Flammer J, Orgul S. Choroidal blood flow response to isometric exercise in glaucoma patients and patients with ocular hypertension. Invest Ophthalmol Vis Sci. 2011 Sep 9;52(10):7068-73. doi: 10.1167/iovs.11-7758.

    PMID: 21828157DERIVED

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 ONLY
Time Perspective
CROSS SECTIONAL
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

December 1, 2013

Study Completion

December 1, 2013

Last Updated

December 11, 2013

Record last verified: 2013-12

Locations

CH(1)