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Completed

NCT Number: NCT01923454

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

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).

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Key information

Conditions

Glaucoma, Angle-Closure Eye Diseases Glaucoma Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Naris Kitnarong

Bangkok, 10700, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: A 30-gauge needle

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.

Other names: Acetazolamide (Diamox 250 mg)

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.

Other names: Laser peripheral iridotomy

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

    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

Other outcomes

  1. visual acuity

    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

    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.

Sponsors and collaborators

Lead sponsor

Siriraj Hospital

Other

Registry information

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Aug 15, 2013
Registry last updated
Aug 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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