Immediate Anterior Chamber Paracentesis With A 30-Gauge Needle for Acute Primary Angle - Closure

Not Applicable

Completed

• Conditions: Glaucoma, Angle-closure
• Interventions: Procedure: Paracentesis; Drug: Acetazolamide; Procedure: Peripheral iridotomy

• Registration Number: NCT01923454
• Lead Sponsor: Siriraj Hospital

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.

Study Timeline

• Study Start: 2005-12
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Status Verified: 2013-08
• Study First Submitted: 2013-08-04
• Study First Submitted QC: 2013-08-14
• Last Update Submitted: 2013-08-14
• Study First Posted: 2013-08-15
• Last Update Posted: 2013-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• patients aged more than 18 year old with the first attack of APAC
• IOP of more than or equal to 40 mmHg.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Paracentesis	Paracentesis	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
Paracentesis	Acetazolamide	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
Paracentesis	Peripheral iridotomy	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

Primary Outcome Measures

Name	Time	Method
The Intraocular pressure (mmHg)	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.

Secondary Outcome Measures

Name	Time	Method
Numbers of complications	at immediately(within 2 minutes after paracentesis), 15 and 30 minutes, and then 1, 24 and 48 hours after paracentesis.	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

Trial Locations

Locations (1)

Naris Kitnarong; 🇹🇭 Bangkok, Thailand