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Trial registered on ANZCTR

Registration number

ACTRN12609000160235

Ethics application status

Approved

Date submitted

19/02/2009

Date registered

27/03/2009

Date last updated

27/03/2009

Type of registration

Retrospectively registered

Titles & IDs

Public title

Immediate Anterior Chamber Paracentesis for Acute Primary Angle closure

Scientific title

A prospective randomised, controlled clinical trial of the safety and efficacy of Immediate anterior chamber paracentesis in the management of acute primary angle closure

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Acute primary angle closure

Condition category

Condition code

Eye

Diseases / disorders of the eye

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Before anterior chamber paracentesis, the following topical medications were given to the involved eye: 1 drop of 0.5% proxymetacaine hydrochloride every minute for 3 minutes, 1 drop of gatifloxacin (3mg/ml), and an application of antiseptic (5% povidone iodine) for 3 minutes. The paracentesises were performed with aseptic techniques at the slit-lamp biomicroscope. A sterile 15° slit knife was used to make a safe-sealing stab incision in the temporal quadrant of the peripheral cornea to relieve aqueous (~0.05 ml) from the anterior chamber.After anterior chamber paracentesis, the following topical medications were administered: 0.5% proxymetacaine hydrochloride once, gatifloxacin (3mg/ml) 1drop after paracentesis and then two hourly for 1day and then six times per day, 4% pilocarpine 1 drop after paracentesis and then every 10 minutes for 1 hours and then two hourly until definitive laser peripheral iridotomy was performed (within 48 hours from paracentesis), 0.5% timolol maleate gellan 1 drop after paracentesis and then once daily. In addition to topical medications, each patient also received i slows intravenous 20% mannitol (200ml) over 1 hour and then methazolamide tablets, 100mg three times daily for 1 day.

Intervention code [1]

Treatment: Surgery

Comparator / control treatment

1% pilocarpine 1 drop after paracentesis and then every 10 minutes for 1 hours and then two hourly until definitive laser peripheral iridotomy was performed (within 48 hours from paracentesis), 0.5% timolol maleate gellan 1 drop after paracentesis and then once daily. In addition to topical medications, each patient also received i slows intravenous 20% mannitol (200ml) over 1 hour and then methazolamide tablets, 100mg three times daily for 1 day.

Control group

Active

Outcomes

Primary outcome [1]

intraocular pressure mesured by Goldmann applanation tonometry

Timepoint [1]

15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 1day, 1week, 1month , 3 months and then at 3-monthly intervals after commencement of treatment at 1week, 1month , 3 months and then at 3-monthly intervals for 12 months.

Primary outcome [2]

pain was evaluated by means of a behavioral rating scale from 0 to 4 (no pain; low pain; mid-level pain; severe pain?intolerable pain).

Timepoint [2]

at presentation, 1 hour, 2 hours and 1 day after commencement of treatment

Secondary outcome [1]

complications (Detailed funduscopy, ultrasound biomicroscope (Paradigm Medical Industries, Inc., Salt Lake City, Utah) and B-scan ultrasonography (I3 System, Innovative Imaging, Sacramento, Calif, USA) were performed to monitor complications.

Timepoint [1]

1 days after commencement of treatment and then at 3-monthly intervals for 12 months.

Secondary outcome [2]

Peripheral anterior synechiae (Gonioscopic examination was performed by the same observer using a Goldmann-type, one-mirror lens to observe peripheral anterior synechiae at the slit lamp under topical anaesthesia. the extent of peripheral anterior synechiae were graded from 1 to 4 (<=90 degree,>90 degree, >180degree, >270 degree)).

Timepoint [2]

1day, 1months and then at 3-monthly intervals for 12 months

Eligibility

Key inclusion criteria

(1) Intraocular pressure levels of 50 mmhg or more (by Goldman applanation tonometry);(2) ability to give informed consent and to cooperate for slit-lamp anterior chamber paracentesis procedure; (3) Duration of attack, as determined by the onset of symptoms, of 72 hours or less; (4) no medical contraindication to systemic acetazolamide or mannitol treatment; (5) the cornea edema rendering immediate laser peripheral iridotomy unsafe.

Minimum age

35 Years

Maximum age

81 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

(1) patients who had received antiglaucomatous treatment before being seen by the authors; (2) the eye with acute primary angle closure had previous intraocular surgery; (3) the eye with acute primary angle closurewas patient’s only eye; (4) the eye have other previous ophthalmic disorders that may have a persistent effect on the structure or function of the drainage angle.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

6/10/2006

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

China

State/province [1]

Country [2]

China

State/province [2]

Guangdong province

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center,Sun Yat-sen University

Address [1]

54 South Xianlie Road, Guangzhou, Guangdong Province, 510060,china

Country [1]

China

Primary sponsor type

Hospital

Name

State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center,Sun Yat-sen University

Address

54 South Xianlie Road, Guangzhou, Guangdong Province, 510060,china

Country

China

Secondary sponsor category [1]

University

Name [1]

Sun Yat-sen University

Address [1]

135 West Xingang Road ,Guangzhou, Guangdong Province, 510275,china

Country [1]

China

Ethics approval

Ethics application status

Approved

Summary

Brief summary

Acute primary angle closure is a sight-threatening ocular disease. In acute primary angle closure , sudden sufficiently extensive occlusion of the outflow angle by iris tissue, results in an abrupt rise in the intraocular pressure. Patients with acute primary angle-closure usually have blurred vision, ocular pain, nausea, vomiting and headache. The treatment for acute primary angle closure aims at rapidly reducing intraocular pressure , so as to relieve unpleasant symptoms and also to prevent further irreversible ocular tissue damage, then, treatment in the next step aims to prevent recurrence of the acute disease and also to prevent progression to chronic angle closure glaucoma.
Traditionally, the treatment for acute primary angle closure involves lowering the intraocular pressure with both systemic and topical medications and then subsequently relieving the papillary block by laser peripheral iridotomy. But this conventional management algorithm has many limitations. Aung et al reported that 58.1% of Asian eyes with acute primary angle closure, treated with medications in the conventional manner followed by laser iridotomy, subsequently developed increase in intraocular pressure. This findings raised the suspicion the traditionally treatment for acute primary angle closure. Therefore, in recent years, a number of trials have been undertaken with the hope of moving one step closer to the ideal treatment algorithm for acute primary angle closure . So, a pilot study had proposed anterior chamber paracentesis as an adjunctive therapy in the management of acute primary angle closure. But, to date, only few reports are available that focus on anterior chamber paracentesis in the management of acute primary angle closure . 
Herein, we conducted a prospective, randomized, controlled study to evaluate the safety and efficacy of immediate anterior chamber paracentesis in the management of acute primary angle closure  not amenable to immediate laser peripheral iridotomy.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Wenru Su

Address

54 South Xianlie Road, Guangzhou, Guangdong Province, 510060,china

Country

China

Phone

+86-20-13570364296

Fax

swrth@163.com

Contact person for scientific queries

Name

Wenru Su

Address

54 South Xianlie Road, Guangzhou, Guangdong Province, 510060,china

Country

China

Phone

+86-20-13570364296

Fax

swrth@163.com

No information has been provided regarding IPD availability

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No Supporting Document Provided

Results publications and other study-related documents

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