GlaucomaNCT00428740
Long-Term IOP Fluctuation and VF Progression After Triple Procedure
An observational study of Glaucoma and Filtering Surgery, run by Yonsei University at 1 site in South Korea.
Trial summary
Long-term intraocular pressure (IOP) fluctuation may be significantly associated with the progression of glaucomatous visual field loss, even in patients kept always low IOP after triple procedure, an effective approach for patients with coexisting glaucoma and visually significant cataracts. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Glaucoma, Filtering Surgery, Intraocular Pressure
- How many people
- 300 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2005to Dec 2005
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Underwent triple procedure
- At leas 3 years of follow-up after surgery
- IOP <18mmHg at each postoperative visit
- A minimum of 5 visual field examinations
- A reference visual field defect score of 16 or less
- Good reliability indices of visual field
Who cannot join
- Any other significant ocular diseases or intraocular surgical histories,
- Diseases that may affect visual field or diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-Term Intraocular Pressure Fluctuation and Visual Field Progression in Glaucoma Patients With Low Intraocular Pressure After Triple Procedure
Long-term intraocular pressure (IOP) fluctuation may be significantly associated with the progression of glaucomatous visual field loss, even in patients kept always low IOP after triple procedure, an effective approach for patients with coexisting glaucoma and visually significant cataracts.
Read the detailed description
Previous studies reported that lowering intraocular pressure (IOP) slowed the advancement of visual field damage in glaucoma patients. However, even if the IOP can been substantially lowered, reduction of mean and peak IOP does not always prevent visual field progression.We believe that the long-term IOP fluctuation may play a significant role in visual field deterioration in those patients.
- Conditions
- Glaucoma, Filtering Surgery, Intraocular Pressure
- 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 posted30 Jan 2007 (estimated)
- Study startOct 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Defined population
- Time perspective
- Retrospective
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Investigators
- Gong Je Seong, MD, PhD, Principal investigator, Yondgong Severance Hospital, Yonsei University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00428740
- Sponsor's protocol ID
- 3-2006-0388
- Status last verified
- Jan 2007
- First submitted
- 29 Jan 2007
- Last updated
- 30 Jan 2007
- Results posted
- No
Publications
Hong S, Seong GJ, Hong YJ. Long-term intraocular pressure fluctuation and progressive visual field deterioration in patients with glaucoma and low intraocular pressures after a triple procedure. Arch Ophthalmol. 2007 Aug;125(8):1010-3. doi: 10.1001/archopht.125.8.1010.
PubMed 17698746
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Intraocular Pressure Fluctuation and Visual Field Progression in Glaucoma Patients With Low Intraocular Pressure After Triple Procedure
- ClinicalTrials.gov ID
- NCT00428740
- Acronym / sponsor ID
- 3-2006-0388
- Conditions
- Glaucoma, Filtering Surgery, Intraocular Pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Oct 2005
- Study completion
- Dec 2005
- First posted
- 30 Jan 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.
Long-term intraocular pressure (IOP) fluctuation may be significantly associated with the progression of glaucomatous visual field loss, even in patients kept always low IOP after triple procedure, an effective approach for patients with coexisting glaucoma and visually significant cataracts.
Detailed description
Previous studies reported that lowering intraocular pressure (IOP) slowed the advancement of visual field damage in glaucoma patients. However, even if the IOP can been substantially lowered, reduction of mean and peak IOP does not always prevent visual field progression.We believe that the long-term IOP fluctuation may play a significant role in visual field deterioration in those patients.
Study design
- Observational model
- Defined population
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Underwent triple procedure
- At leas 3 years of follow-up after surgery
- IOP <18mmHg at each postoperative visit
- A minimum of 5 visual field examinations
- A reference visual field defect score of 16 or less
Key exclusion criteria (2 listed)
- Any other significant ocular diseases or intraocular surgical histories,
- Diseases that may affect visual field or diabetes
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 30 Jan 2007.
- Derived from this study: PubMed 17698746Hong S, Seong GJ, Hong YJ. Long-term intraocular pressure fluctuation and progressive visual field deterioration in patients with glaucoma and low intraocular pressures after a triple procedure. Arch Ophthalmol. 2007 Aug;125(8):1010-3. doi: 10.1001/archopht.125.8.1010.
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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.
Gong Je Seong, MD, PhD principal investigator
Yondgong Severance Hospital, 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 Glaucoma and Filtering Surgery, 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 6 inclusion and 2 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 30 Jan 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?
On the ClinicalTrials.gov record for NCT00428740, which also lists 1 linked publication.
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 30 Jan 2007.