Back to resultsImmediate Anterior Chamber Paracentesis With A 30-Gauge Needle for Acute Primary Angle - Closure
Primary Purpose
Glaucoma, Angle-closure
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Paracentesis
Acetazolamide
Peripheral iridotomy
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma, Angle-closure focused on measuring paracentesis, primary acute angle closure, iridotomy, filtration, glaucoma
Eligibility Criteria
Inclusion Criteria:
- patients aged more than 18 year old with the first attack of APAC
- IOP of more than or equal to 40 mmHg.
Exclusion Criteria:
- 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.
Sites / Locations
- Naris Kitnarong
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Paracentesis
Arm Description
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01923454
Brief Title
Immediate Anterior Chamber Paracentesis With A 30-Gauge Needle for Acute Primary Angle - Closure
Official Title
Immediate Anterior Chamber Paracentesis With A 30-Gauge Needle for Acute Primary Angle - Closure
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Siriraj Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Angle-closure
Keywords
paracentesis, primary acute angle closure, iridotomy, filtration, glaucoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Paracentesis
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Paracentesis
Other Intervention Name(s)
A 30-gauge needle
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Acetazolamide
Other Intervention Name(s)
Acetazolamide (Diamox 250 mg)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Peripheral iridotomy
Other Intervention Name(s)
Laser peripheral iridotomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Intraocular pressure (mmHg)
Description
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.
Time Frame
Change of intraocular pressure between before paracentesis and at 48 hours after paracentesis
Secondary Outcome Measure Information:
Title
Numbers of complications
Description
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
Time Frame
at immediately(within 2 minutes after paracentesis), 15 and 30 minutes, and then 1, 24 and 48 hours after paracentesis.
Other Pre-specified Outcome Measures:
Title
visual acuity
Description
The study will record the visual acuity with Snellen's chart at immediately (within 2 minutes after paracentesis), 1 hours, 24 hours and 48 hours after paracentesis.
Time Frame
The change of visual acuity between before paracentesisat and immediately (within 2 minutes) after paracentesis, 1 hours, 24 hours and 48 hours after paracentesis
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients aged more than 18 year old with the first attack of APAC
IOP of more than or equal to 40 mmHg.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naris Kitnarong, M.D.
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Naris Kitnarong
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
12. IPD Sharing Statement
Citations:
PubMed Identifier
18071739
Citation
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.
Results Reference
result
PubMed Identifier
11772581
Citation
Lam 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.
Results Reference
result
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Immediate Anterior Chamber Paracentesis With A 30-Gauge Needle for Acute Primary Angle - Closure
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