Glaucoma, Angle-closureNCT01923454
Immediate Anterior Chamber Paracentesis With A 30-Gauge Needle for Acute Primary Angle - Closure
A study testing Paracentesis, Acetazolamide and Peripheral iridotomy in people with Glaucoma, Angle-closure, run by Siriraj Hospital at 1 site in Thailand.
Trial summary
This study was to evaluate the efficacy and safety of immediate anterior chamber paracentesis (ACP) with a 30-gauge needle as an initial treatment for acute primary angle closure (APAC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Angle-closure
- What is being tested?
- Paracentesis, Acetazolamide and Peripheral iridotomy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteThailand
- Study dates
- Dec 2005to Jun 2007
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients aged more than 18 year old with the first attack of APAC
- IOP of more than or equal to 40 mmHg.
Who cannot join
- patient unable to cooperate for paracentesis
- patients with APAC in the only remaining eye
- patients received any glaucoma treatments prior to the study
- patients with secondary causes of acute angle closure
- patients with intraocular inflammation or infection; (6) patients with APAC in the eye with a history of previous intraocular surgery
- patients known hypersensitive to tetracaine hydrochloride or tobramycin.
Trial locations and contacts
1 site in 1 country.
About this study
This study was to evaluate the efficacy and safety of immediate anterior chamber paracentesis (ACP) with a 30-gauge needle as an initial treatment for acute primary angle closure (APAC).
Read the detailed description
This is a prospective study from patients with APAC presenting at the Faculty of Medicine Siriraj Hospital, Bangkok, Thailand in 2005. At presentation, patients received immediate ACP with a 30-gauge needle. The IOP, best corrected visual acuity (BCVA), corneal edema grading, pupil size and symptoms were recorded at immediately, 15 and 30 minutes, and then 1, 24 and 48 hours after paracentesis. All affected eyes received antiglaucomatous medications 60 minutes after ACP and underwent peripheral iridotomy within 24 hours.
- Conditions
- Glaucoma, Angle-closure
- Being tested
- Paracentesis, Acetazolamide, Peripheral iridotomy
- Keywords
- paracentesis, primary acute angle closure, iridotomy, filtration, glaucoma
- Medical subject headings
- Glaucoma, Angle-Closure, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParacentesisProcedure or surgery
Also called A 30-gauge needle
At presentation, patients received immediate anterior chamber paracentesis with a 30-gauge needle. The intraocular pressure (IOP) was recorded at immediately, 15 and 30 minutes, and then 1, 24 and 48 hours after paracentesis. The IOP was compared between before paracentesis and each time-point after paracentesis. All affected eyes received antiglaucomatous medications 60 minutes after ACP and underwent peripheral iridotomy within 24 hours.
AcetazolamideDrug
Also called Acetazolamide (Diamox 250 mg)
All participants will receive oral acetazolamide (250 mg) 1 tablet at 1 hour after paracentesis to lower the intraocular pressure. After that, the dose of acetazolamide will be adjusted according to the level of intraocular pressure. If the eye pressure goes to normal (lower than 21 mmHg), acetazolamide will be discontinued.
Peripheral iridotomyProcedure or surgery
Also called Laser peripheral iridotomy
All affected eyes underwent laser peripheral iridotomy within 24 hours after presentation. This procedure is a standard treatment for acute angle-closure. The fellow eyes will receive laser peripheral iridotomy in the same occasion or later to prevent acute angle-closure in the future.
| Study group | Role | What they receive |
|---|---|---|
| Paracentesis | Experimental | Immediate anterior chamber paracentesis (ACP) with a 30-gauge needle as an initial treatment for acute primary angle closure.
Acetamide, given in this study, is a standard treatment for acute angle-closure glaucoma. The participant will receive 1 tablet(250mg) at 1 hours after paracentesis. The following dose will be adjusted according to the level of IOP. The maximal dose is 4 tablets per day. It will be discontinued if the IOP is less than 21 mmHg.
All affected eyes will receive laser peripheral iridotomy with 24 hours after presentation. This a standard treatment for Acute angle-closure glaucoma Receives: Procedure: Paracentesis; Drug: Acetazolamide; Procedure: Peripheral iridotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Intraocular pressure (mmHg)
The intraocular pressure (IOP) was recorded at immediately(within 2 minutes after paracentesis), 15 and 30 minutes, and then 1, 24 and 48 hours after paracentesis. The change of IOP was study between before paracentesis and at each time-point. All affected eyes received antiglaucomatous medications 60 minutes after paracentesis and underwent peripheral iridotomy within 24 hours.
Measured: Change of intraocular pressure between before paracentesis and at 48 hours after paracentesis
Secondary outcomes (1)
Numbers of complications
This is to observe the potential complications which may occur during and after paracentesis with a 30-gauge needle. Among the potential complications include lens capsular rupture, hyphema, retinal hemorrhage, hypotony and infection. The study will record each complications as numbers of events at each time-point until 48 hours after paracentesis
Measured: at immediately(within 2 minutes after paracentesis), 15 and 30 minutes, and then 1, 24 and 48 hours after paracentesis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2013 (estimated)
- Study startDec 2005
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Glaucoma, Angle-closureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siriraj Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naris Kitnarong, Siriraj Hospital
- Investigators
- Naris Kitnarong, M.D., Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01923454
- Sponsor's protocol ID
- NK001
- Status last verified
- Aug 2013
- First submitted
- 4 Aug 2013
- Last updated
- 15 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pong JC. Anterior chamber paracentesis in patients with acute elevation of intraocular pressure. Graefes Arch Clin Exp Ophthalmol. 2008 Mar;246(3):463-4; author reply 465-6. doi: 10.1007/s00417-007-0675-5. Epub 2007 Dec 11. No abstract available.
PubMed 18071739Lam DS, Chua JK, Tham CC, Lai JS. Efficacy and safety of immediate anterior chamber paracentesis in the treatment of acute primary angle-closure glaucoma: a pilot study. Ophthalmology. 2002 Jan;109(1):64-70. doi: 10.1016/s0161-6420(01)00857-0.
PubMed 11772581
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Anterior Chamber Paracentesis With A 30-Gauge Needle for Acute Primary Angle - Closure
- ClinicalTrials.gov ID
- NCT01923454
- Acronym / sponsor ID
- NK001
- Conditions
- Glaucoma, Angle-closure
- Keywords
- paracentesis, primary acute angle closure, iridotomy, filtration, glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Siriraj HospitalUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 15 Aug 2013 (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.
This study was to evaluate the efficacy and safety of immediate anterior chamber paracentesis (ACP) with a 30-gauge needle as an initial treatment for acute primary angle closure (APAC).
Detailed description
This is a prospective study from patients with APAC presenting at the Faculty of Medicine Siriraj Hospital, Bangkok, Thailand in 2005. At presentation, patients received immediate ACP with a 30-gauge needle. The IOP, best corrected visual acuity (BCVA), corneal edema grading, pupil size and symptoms were recorded at immediately, 15 and 30 minutes, and then 1, 24 and 48 hours after paracentesis. All affected eyes received antiglaucomatous medications 60 minutes after ACP and underwent peripheral iridotomy within 24 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paracentesis | Experimental | Procedure: Paracentesis, Drug: Acetazolamide, Procedure: Peripheral iridotomyImmediate anterior chamber paracentesis (ACP) with a 30-gauge needle as an initial treatment for acute primary angle closure. Acetamide, given in this study, is a standard treatment for acute angle-closure glaucoma. The participant will receive 1 tablet(250mg) at 1 hours after paracentesis. The following dose will be adjusted according to the level of IOP. The maximal dose is 4 tablets per day. It will be discontinued if the IOP is less than 21 mmHg. All affected eyes will receive laser peripheral iridotomy with 24 hours after presentation. This a standard treatment for Acute angle-closure glaucoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients aged more than 18 year old with the first attack of APAC
- IOP of more than or equal to 40 mmHg.
Key exclusion criteria (6 listed)
- patient unable to cooperate for paracentesis
- patients with APAC in the only remaining eye
- patients received any glaucoma treatments prior to the study
- patients with secondary causes of acute angle closure
- patients with intraocular inflammation or infection; (6) patients with APAC in the eye with a history of previous intraocular surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ParacentesisAlso: A 30-gauge needleAt presentation, patients received immediate anterior chamber paracentesis with a 30-gauge needle. The intraocular pressure (IOP) was recorded at immediately, 15 and 30 minutes, and then 1, 24 and 48 hours after paracentesis. The IOP was compared between before paracentesis and each time-point after paracentesis. All affected eyes received antiglaucomatous medications 60 minutes after ACP and underwent peripheral iridotomy within 24 hours. | Procedure or surgery | Paracentesis |
| AcetazolamideAlso: Acetazolamide (Diamox 250 mg)All participants will receive oral acetazolamide (250 mg) 1 tablet at 1 hour after paracentesis to lower the intraocular pressure. After that, the dose of acetazolamide will be adjusted according to the level of intraocular pressure. If the eye pressure goes to normal (lower than 21 mmHg), acetazolamide will be discontinued. | Drug | Paracentesis |
| Peripheral iridotomyAlso: Laser peripheral iridotomyAll affected eyes underwent laser peripheral iridotomy within 24 hours after presentation. This procedure is a standard treatment for acute angle-closure. The fellow eyes will receive laser peripheral iridotomy in the same occasion or later to prevent acute angle-closure in the future. | Procedure or surgery | Paracentesis |
Primary outcome
The Intraocular pressure (mmHg)
Time frame: Change of intraocular pressure between before paracentesis and at 48 hours after paracentesis
The intraocular pressure (IOP) was recorded at immediately(within 2 minutes after paracentesis), 15 and 30 minutes, and then 1, 24 and 48 hours after paracentesis. The change of IOP was study between before paracentesis and at each time-point. All affected eyes received antiglaucomatous medications 60 minutes after paracentesis and underwent peripheral iridotomy within 24 hours.
1 secondary outcome
Numbers of complications
Time frame: at immediately(within 2 minutes after paracentesis), 15 and 30 minutes, and then 1, 24 and 48 hours after paracentesis.
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 15 Aug 2013.
- Results publication: PubMed 18071739Pong JC. Anterior chamber paracentesis in patients with acute elevation of intraocular pressure. Graefes Arch Clin Exp Ophthalmol. 2008 Mar;246(3):463-4; author reply 465-6. doi: 10.1007/s00417-007-0675-5. Epub 2007 Dec 11. No abstract available.
- Results publication: PubMed 11772581Lam DS, Chua JK, Tham CC, Lai JS. Efficacy and safety of immediate anterior chamber paracentesis in the treatment of acute primary angle-closure glaucoma: a pilot study. Ophthalmology. 2002 Jan;109(1):64-70. doi: 10.1016/s0161-6420(01)00857-0.
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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.
Naris Kitnarong, M.D. principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paracentesis, Acetazolamide and Peripheral iridotomy in people with Glaucoma, Angle-closure, run by Siriraj Hospital at 1 site in Thailand.
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 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 15 Aug 2013. 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 Thailand. 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.
What does the primary outcome measure?
The Intraocular pressure (mmHg) (time frame: Change of intraocular pressure between before paracentesis and at 48 hours after paracentesis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01923454, which also lists 2 linked publications.
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 15 Aug 2013.