Open-Angle GlaucomaIOPMGNCT00481208
Diurnal Intraocular Pressure and Peripapillary Retinal Blood Flow in Medically Controlled Open-Angle Glaucoma
An observational study of Open-Angle Glaucoma, run by Yonsei University at 1 site in South Korea.
Trial summary
Diurnal fluctuations of intraocular pressure (IOP) and peripapillary retinal blood flow may have distinctive patterns in medically well-controlled open-angle glaucoma patients. In the results, we found a unique pattern, 'Latent asymmetric IOP', defined as the IOP which differs between the eyes only when placed in the… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Open-Angle Glaucoma
- How many people
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2006to Nov 2006
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Open-angle glaucoma
- Topical anti-glaucoma medications
Who cannot join
- Ocular surgery history
- Other ocular disease history
- Oral glaucoma medications
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Severance Hospital, Yonsei University College of Medicine
Seoul, 120-752
About this study
Diurnal fluctuations of intraocular pressure (IOP) and peripapillary retinal blood flow may have distinctive patterns in medically well-controlled open-angle glaucoma patients. In the results, we found a unique pattern, 'Latent asymmetric IOP', defined as the IOP which differs between the eyes only when placed in the supine position. Unique effects of this latent asymmetric IOP on Visual field and diurnal IOP fluctuations were studied.
Read the detailed description
Diurnal fluctuations of intraocular pressure (IOP) and peripapillary retinal blood flow have been implicated to be one of the important factors to affect visual field progression. However, there was no study to investigate them in medically well-controlled open-angle glaucoma patients. So we want to find the unique patterns.
Study 1. Subjects : Patients with medically well controlled open angle glaucoma Method : IOP and peripapillary retinal blood flow were measured for 24 hours. The relationship between the two were studied.
Study 2. Of the patients enrolled in study 1 , those on the same medical regimen for both eyes were analyzed for the presence of a latent asymmetric IOP and it's influence and association with visual field and diurnal IOP fluctuation.
- Conditions
- Open-Angle Glaucoma
- Keywords
- open-angle glaucoma, diurnal fluctuation, intraocular pressure, peripapillary retinal blood flow, latent asymmetric intraocular pressure
- 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 posted1 Jun 2007 (estimated)
- Study startMar 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open-Angle GlaucomaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Natural history
- Time perspective
- Other
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Investigators
- Chan Yun Kim, MD, PhD, Study chair, Department of Ophthalmology, Yonsei University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00481208
- Sponsor's protocol ID
- 4-2006-0146
- Acronym
- IOPMG
- Status last verified
- May 2007
- First submitted
- 31 May 2007
- Last updated
- 1 Jun 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diurnal Intraocular Pressure and Peripapillary Retinal Blood Flow in Medically Controlled Open-Angle Glaucoma
- ClinicalTrials.gov ID
- NCT00481208
- Acronym / sponsor ID
- IOPMG / 4-2006-0146
- Conditions
- Open-Angle Glaucoma
- Keywords
- open-angle glaucoma, diurnal fluctuation, intraocular pressure, peripapillary retinal blood flow, latent asymmetric intraocular pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Mar 2006
- Study completion
- Nov 2006 (actual)
- First posted
- 1 Jun 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.
Diurnal fluctuations of intraocular pressure (IOP) and peripapillary retinal blood flow may have distinctive patterns in medically well-controlled open-angle glaucoma patients. In the results, we found a unique pattern, 'Latent asymmetric IOP', defined as the IOP which differs between the eyes only when placed in the supine position. Unique effects of this latent asymmetric IOP on Visual field and diurnal IOP fluctuations were studied.
Detailed description
Diurnal fluctuations of intraocular pressure (IOP) and peripapillary retinal blood flow have been implicated to be one of the important factors to affect visual field progression. However, there was no study to investigate them in medically well-controlled open-angle glaucoma patients. So we want to find the unique patterns.
Study 1. Subjects : Patients with medically well controlled open angle glaucoma Method : IOP and peripapillary retinal blood flow were measured for 24 hours. The relationship between the two were studied.
Study 2. Of the patients enrolled in study 1 , those on the same medical regimen for both eyes were analyzed for the presence of a latent asymmetric IOP and it's influence and association with visual field and diurnal IOP fluctuation.
Study design
- Observational model
- Natural history
- Time perspective
- Other
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Open-angle glaucoma
- Topical anti-glaucoma medications
Key exclusion criteria (3 listed)
- Ocular surgery history
- Other ocular disease history
- Oral glaucoma medications
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 1 Jun 2007.
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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.
Chan Yun Kim, MD, PhD study chair
Department of Ophthalmology, Yonsei University College of Medicine
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 Open-Angle Glaucoma, run by Yonsei University at 1 site in South Korea.
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: finished, as of the sponsor's last update on 1 Jun 2007. 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 South Korea. 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 1 Jun 2007.