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.
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.
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.
- First posted1 Feb 2007 (estimated)
- Study startJan 2006
- Primary completionAug 2009
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Selim Orguel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Selim Orguel, University Hospital, Basel, Switzerland
- Investigators
- Selim Orgül, MD, Study director, University Eye Clinic Basel
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photographic Imaging of the Retina and Optic Nerve Head of Glaucoma Patients and Normal Controls
- ClinicalTrials.gov ID
- NCT00430274
- Acronym / sponsor ID
- 073-GRM-2006-001
- Conditions
- Glaucoma
- Keywords
- glaucoma, retinal gliosis-like alterations, optical coherence tomography, automated microperimetry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Selim OrguelUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Aug 2009 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 1 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients with vascular dysregulation
Key inclusion criteria (17 listed)
- untreated intraocular pressure equal to or less than 21mmHg or
- median intraocular pressure equal to or less than 20mmHg
- mean untreated intraocular pressure more than 21mmHg
- open drainage angles on gonioscopy
- typical optic disc damage with glaucomatous cupping and thinning of neuroretinal rim
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Selim Orgül, MD study director
University Eye Clinic Basel
1 site in 1 country: see every site and its status.
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.