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

Glaucoma, Angle-closure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01923454
• Other study ID #: NK001
• Status: Completed
• Phase: N/A
• First received: August 4, 2013
• Last updated: August 14, 2013
• Start date: December 2005
• Est. completion date: June 2007

Study information

• Verified date: August 2013
• Source: Siriraj Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma, Angle-closure

Intervention

Procedure:
• Paracentesis
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.

Drug:
• Acetazolamide
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.

Procedure:
• 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.

Locations

Country	Name	City	State
Thailand	Naris Kitnarong	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Siriraj Hospital

Country where clinical trial is conducted

Thailand, 

References & Publications (2)

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. — View 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. Epub 2007 Dec 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	visual acuity	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.	The change of visual acuity between before paracentesisat and immediately (within 2 minutes) after paracentesis, 1 hours, 24 hours and 48 hours after paracentesis	No
Primary	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.	Change of intraocular pressure between before paracentesis and at 48 hours after paracentesis	No
Secondary	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	at immediately(within 2 minutes after paracentesis), 15 and 30 minutes, and then 1, 24 and 48 hours after paracentesis.	Yes