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GlaucomaNCT00430274

Photographic Imaging of the Retina and Optic Nerve Head of Glaucoma Patients and Normal Controls

An observational study of Glaucoma, run by Selim Orguel at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Glaucoma
How many people
120 participants
Where
1 siteSwitzerland
Study dates
Jan 2006to Apr 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: patients with vascular dysregulation

Who may be able to join

  • 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:
Show all 17Show fewer
  • 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
  • no pathological findings upon a slit-lamp examination and fundoscopy
  • IOP < 21 mmHg in both eyes

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • University Eye Clinic

    Basel, 4031

Other trials in Switzerland

About this study

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.

Read the detailed description

Glaucoma is an optic neuropathy characterized by a progressive loss of retinal ganglion cells and cupping of the optic nerve head associated with visual function defects. Increased intraocular pressure and vascular alterations such as unsteady blood flow have been implicated in the pathogenesis of glaucoma. While glaucoma changes occur in both the retina and the optic nerve head, clinical diagnosis normally focuses on optic nerve head. However, histomorphologic and immunohistochemistry studies have shown that glial cells in the retina (astrocytes and Müller cells) are also activated in glaucoma. In addition, some patients with glaucoma have clinically patchy alteration in the retina resembling epiretinal gliosis but without visual disturbance, thus the term "gliosis-like alterations" was used previously. At present however, it is unknown whether gliosis-like alterations are associated with a specific type of glaucoma (i.e. high- or normal-tension glaucoma) or with vascular dysregulation. Moreover, it remains unclear whether gliosis-like alterations may also occur in the elderly patients without glaucoma as an aging process of the retina. Retinal structures are difficult to visualize and details difficult to be imaged on a photograph because the retina is optically transparent. Blue light scatters more than red light. This is the reason why the retinal nerve fiber layer can to some extent be better visualized with red-free light. The extensions of the astrocytes in the retina form a fine meshwork, which becomes denser and irregular as these astrocytes are activated. The size and numbers of glial cells increase, as the neural cell damage advances. These changes, in turn, may increase the light scattering. With appropriate technology, increased reflection and light scattering from the retina may be detected in the retina of glaucoma patients. The purpose of the study is to evaluate whether gliosis-like alterations do occur more often in glaucoma.

The retina of patients and healthy controls alike will be photographically documented with a digital fundus camera as well as with optical coherence tomography and automated microperimetry that enables to correlate objectively local morphologic aspects and changes of the retina with local functional measurements. Possible causes for secondary retinal gliosis will be excluded in a thorough clinical examination including slit-lamp examination and dilated direct fundoscopy. The examination techniques and interventions used in this study are routine clinical practice and do not expose patients or controls to undue risk.

Conditions
Glaucoma
Keywords
glaucoma, retinal gliosis-like alterations, optical coherence tomography, automated microperimetry
Medical subject headings
Glaucoma

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2007 (estimated)
  2. Study startJan 2006
  3. Primary completionAug 2009
  4. Study completionApr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00430274
Sponsor's protocol ID
073-GRM-2006-001
Status last verified
Aug 2017
First submitted
31 Jan 2007
Last updated
25 Aug 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Glaucoma, run by Selim Orguel at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2017.

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