Primary Open Angle GlaucomaNCT01346904
a 3.0T Magnetic Resonance Imaging Study
An observational study of Primary Open Angle Glaucoma, run by Huazhong University of Science and Technology.
Trial summary
Glaucomatous damage not only occurred to retinal ganglion cells in the eyes, but went across optic nerves, visual chiasm, lateral geniculate nucleus (LGN) and finally the visual cortex; the neural degenerations could be identified through the whole visual tract, which suggests the central nerve system may play a vital… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Primary Open Angle Glaucoma
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- May 2011to Dec 2012
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All subjects recruited from the Department of Ophthalmology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology. Clinical ophthalmic assessments including measurement of visual acuities, intraocular pressure, slit-lamp microscopes and funduscopes examinations, cup-to-dick ratio (CDR) evaluation, visual field test [Octopus 101 Automated Perimeter, Haag-streit, Switzerland. Program G2], optical coherence tomography for retinal nerve fiber layer thickness(RNFLT) around the optic disk[Stratus OCT，Carl Zeiss Meditec, Dublin, CA .Scan Type :Fast RNFLT 3.4, Scan Length: 10.87mm].
Who may be able to join
- Primary open angle glaucoma diagnosed on the basis of glaucomatous optic disc cupping ratio (in particular, thinning of the inferior and/or superior rim, cup-to-disc ratio asymmetry of >0.2)
- matching glaucomatous visual field defects (European Glaucoma Society (2008) Perimetry )
Who cannot join
- optic neuropathy
- neurological disorder
- other diseases and use of systemic medications which affect optic nerve or the visual field underwent complete eye examination and visual-field testing.
About this study
Official title: The Central Nerve System Injury in Patients With Primary Open Angle Glaucoma
Glaucomatous damage not only occurred to retinal ganglion cells in the eyes, but went across optic nerves, visual chiasm, lateral geniculate nucleus (LGN) and finally the visual cortex; the neural degenerations could be identified through the whole visual tract, which suggests the central nerve system may play a vital role in the progression of glaucoma. The investigators used MRI to investigate changes of visual pathway in vivo.
- Conditions
- Primary Open Angle Glaucoma
- Medical subject headings
- Glaucoma, Open-Angle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2011 (estimated)
- Study startMay 2011
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open Angle 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-sen University
- Investigators
- HONG ZHANG, PHD, Study chair, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01346904
- Sponsor's protocol ID
- POAG3243
- Status last verified
- May 2011
- First submitted
- 2 May 2011
- Last updated
- 3 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Central Nerve System Injury in Patients With Primary Open Angle Glaucoma
- ClinicalTrials.gov ID
- NCT01346904
- Acronym / sponsor ID
- POAG3243
- Conditions
- Primary Open Angle Glaucoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Sun Yat-sen University
- Study start
- May 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 3 May 2011 (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.
Glaucomatous damage not only occurred to retinal ganglion cells in the eyes, but went across optic nerves, visual chiasm, lateral geniculate nucleus (LGN) and finally the visual cortex; the neural degenerations could be identified through the whole visual tract, which suggests the central nerve system may play a vital role in the progression of glaucoma. The investigators used MRI to investigate changes of visual pathway in vivo.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All subjects recruited from the Department of Ophthalmology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology. Clinical ophthalmic assessments including measurement of visual acuities, intraocular pressure, slit-lamp microscopes and funduscopes examinations, cup-to-dick ratio (CDR) evaluation, visual field test [Octopus 101 Automated Perimeter, Haag-streit, Switzerland. Program G2], optical coherence tomography for retinal nerve fiber layer thickness(RNFLT) around the optic disk[Stratus OCT，Carl Zeiss Meditec, Dublin, CA .Scan Type :Fast RNFLT 3.4, Scan Length: 10.87mm].
Key inclusion criteria (2 listed)
- Primary open angle glaucoma diagnosed on the basis of glaucomatous optic disc cupping ratio (in particular, thinning of the inferior and/or superior rim, cup-to-disc ratio asymmetry of >0.2)
- matching glaucomatous visual field defects (European Glaucoma Society (2008) Perimetry )
Key exclusion criteria (3 listed)
- optic neuropathy
- neurological disorder
- other diseases and use of systemic medications which affect optic nerve or the visual field underwent complete eye examination and visual-field testing.
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2011.
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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.
HONG ZHANG, PHD study chair
Tongji Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Open Angle Glaucoma, run by Huazhong University of Science and Technology.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 3 May 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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 3 May 2011.