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

NCT01923454 | Completed DMC

• 1 other identifier: NK001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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).

Conditions

Glaucoma, Angle-closure

Keywords

paracentesis; primary acute angle closure; iridotomy; filtration; glaucoma

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Numbers of complications

  at immediately(within 2 minutes after paracentesis), 15 and 30 minutes, and then 1, 24 and 48 hours after paracentesis.

Other Outcomes (1)

• visual acuity

  The change of visual acuity between before paracentesisat and immediately (within 2 minutes) after paracentesis, 1 hours, 24 hours and 48 hours after paracentesis

Study Arms (1)

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

Procedure: Paracentesis; Drug: Acetazolamide; Procedure: Peripheral iridotomy

Interventions

Paracentesis PROCEDURE

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.

Also known as: A 30-gauge needle

Paracentesis

Acetazolamide DRUG

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.

Also known as: Acetazolamide (Diamox 250 mg)

Paracentesis

Peripheral iridotomy PROCEDURE

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.

Also known as: Laser peripheral iridotomy

Paracentesis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Siriraj Hospital: lead

Study Sites (1)

Naris Kitnarong

Bangkok, Bangkok, 10700, Thailand

Location

Related Publications (2)

• 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.

  PMID: 18071739 RESULT

• 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.

  PMID: 11772581 RESULT

MeSH Terms

Conditions

Glaucoma, Angle-Closure; Glaucoma

Interventions

Paracentesis; Acetazolamide

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Drainage; Therapeutics; Punctures; Surgical Procedures, Operative; Investigative Techniques; Thiadiazoles; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Naris Kitnarong, M.D.

  Mahidol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: August 4, 2013
• First Posted: August 15, 2013
• Study Start: December 1, 2005
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: August 15, 2013

Record last verified: 2013-08

Locations

TH (1)