GlaucomaNCT01266343
Comparison of Anterior Chamber Paracentesis and Conventional Mannitol Infusion in Patients With Primary Acute Angle-closure Glaucoma
An observational study of Glaucoma and Acute Primary Angle-closure Glaucoma, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial summary
The investigators wanted to reported the results of immediate anterior chamber paracentesis (ACP), compared to Mannitol infusion, in patients with acute primary angle-closure glaucoma (PACG). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Glaucoma, Acute Primary Angle-closure Glaucoma
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2007to Dec 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Glaucoma patients
Who may be able to join
- first attack of acute PACG;
- initial presenting IOP was higher than 45 mmHg;
- diagnosis confirmed by gonioscopic examination;
- patients within 48 hours of symptom onset.
Who cannot join
- been incompletely followed up within 2 weeks;
- been using anti-glaucomatous medication before ACP or Mannitol infusion;
- previous intraocular surgeries on the same eye;
- contraindication for Mannitol;
- history of other vision-threatening ocular diseases.
Trial locations and contacts
1 site in 1 country.
About this study
The investigators wanted to reported the results of immediate anterior chamber paracentesis (ACP), compared to Mannitol infusion, in patients with acute primary angle-closure glaucoma (PACG). In this study, the investigators first divided patients into three sub-groups according to their initial intraocular pressure (IOP) for analyzing the differences of IOP control, severity of corneal edema, waiting time for laser peripheral iridotomy (LPI), and visual outcome between ACP and Mannitol infusion.
Read the detailed description
The investigators demonstrated that ACP could be first considered in patients with initial IOP between 45 to 60 mmHg because it provided better visual outcome than Mannitol infusion through the rapid stabilization of the anterior segment, which was achieved by rapid IOP control, better corneal edema regression, shortening waiting time for LPI. However, ACP should be considered in patients with the initial IOP of 60mmHg and higher only when Mannitol was contraindicated.
- Conditions
- Glaucoma, Acute Primary Angle-closure Glaucoma
- Keywords
- Glaucoma, anterior chamber paracentesis, conventional Mannitol infusion
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Not described | |
| Control Group | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2010 (estimated)
- Study startJan 2007
- Study completionDec 2009
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-control
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Hui-Chun Ho, Principal investigator, Taipei Medical University WanFang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01266343
- Sponsor's protocol ID
- 99018
- Status last verified
- Dec 2010
- First submitted
- 22 Dec 2010
- Last updated
- 24 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Anterior Chamber Paracentesis and Conventional Mannitol Infusion in Patients With Primary Acute Angle-closure Glaucoma
- ClinicalTrials.gov ID
- NCT01266343
- Acronym / sponsor ID
- 99018
- Conditions
- Glaucoma, Acute Primary Angle-closure Glaucoma
- Keywords
- Glaucoma, anterior chamber paracentesis, conventional Mannitol infusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- Jan 2007
- Study completion
- Dec 2009 (actual)
- First posted
- 24 Dec 2010 (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.
The investigators wanted to reported the results of immediate anterior chamber paracentesis (ACP), compared to Mannitol infusion, in patients with acute primary angle-closure glaucoma (PACG). In this study, the investigators first divided patients into three sub-groups according to their initial intraocular pressure (IOP) for analyzing the differences of IOP control, severity of corneal edema, waiting time for laser peripheral iridotomy (LPI), and visual outcome between ACP and Mannitol infusion.
Detailed description
The investigators demonstrated that ACP could be first considered in patients with initial IOP between 45 to 60 mmHg because it provided better visual outcome than Mannitol infusion through the rapid stabilization of the anterior segment, which was achieved by rapid IOP control, better corneal edema regression, shortening waiting time for LPI. However, ACP should be considered in patients with the initial IOP of 60mmHg and higher only when Mannitol was contraindicated.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | – | – |
| Control Group | – | – |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Glaucoma patients
Key inclusion criteria (4 listed)
- first attack of acute PACG;
- initial presenting IOP was higher than 45 mmHg;
- diagnosis confirmed by gonioscopic examination;
- patients within 48 hours of symptom onset.
Key exclusion criteria (5 listed)
- been incompletely followed up within 2 weeks;
- been using anti-glaucomatous medication before ACP or Mannitol infusion;
- previous intraocular surgeries on the same eye;
- contraindication for Mannitol;
- history of other vision-threatening ocular diseases.
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 24 Dec 2010.
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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.
Hui-Chun Ho principal investigator
Taipei Medical University WanFang Hospital
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 Acute Primary Angle-closure Glaucoma, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
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 4 inclusion and 5 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 24 Dec 2010. 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 Taiwan. 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 24 Dec 2010.