NCT00430274

Brief Summary

Retinal structures are difficult to visualize because the retina is optically transparent. In glaucoma, the microglia in the retina becomes activated in eyes with glaucomatous damage. The microglia forms a dense meshwork which resembles gliosis-like alterations, which may increase light scattering. With appropriate technology, increased reflection and light scattering from the retina may be detected in eyes of glaucoma patients. In this study, we investigate whether clinically observable retinal gliosis-like alterations occur more often in patients with glaucoma than in non-glaucomatous controls, and whether gliosis-like alterations are associated with a vasospastic propensity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
1.1 years 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
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
7.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

August 25, 2017

Status Verified

August 1, 2017

Enrollment Period

3.6 years

First QC Date

January 31, 2007

Last Update Submit

August 24, 2017

Conditions

Keywords

glaucomaretinal gliosis-like alterationsoptical coherence tomographyautomated microperimetry

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with vascular dysregulation

You may qualify if:

  • For NTG patients :
  • untreated intraocular pressure equal to or less than 21mmHg or
  • median intraocular pressure equal to or less than 20mmHg
  • For HTG patients:
  • mean untreated intraocular pressure more than 21mmHg
  • For both:
  • open drainage angles on gonioscopy
  • typical optic disc damage with glaucomatous cupping and thinning of neuroretinal rim
  • absence of any secondary cause for a glaucomatous optic neuropathy
  • visual field defects congruent to glaucomatous disc damage (disc/field correlation)
  • Healthy subjects:
  • no history of ocular diseases
  • no current topical medication
  • no drug or alcohol abuse
  • best corrected visual acuity above 20/25 in both eyes
  • +2 more criteria

You may not qualify if:

  • For NTG and HTG patients:
  • any other form of retinal or neuroophthalmological disease that could cause gliosis-like retinal alterations or result in visual field defects
  • history of chronic or recurrent severe inflammatory eye disease
  • history of ocular trauma or intraocular surgery
  • history of infection or inflammation within the past 3 months
  • history and clinical evidence for other retinal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Eye Clinic

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Selim Orgül, MD

    University Eye Clinic Basel

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

January 31, 2007

First Posted

February 1, 2007

Study Start

January 1, 2006

Primary Completion

August 1, 2009

Study Completion

April 1, 2017

Last Updated

August 25, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations