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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 4358 0
Condition category
Condition code
Eye 4603 4603 0 0
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] 4092 0
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] 5479 0
intraocular pressure mesured by Goldmann applanation tonometry
Timepoint [1] 5479 0
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] 5480 0
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] 5480 0
at presentation, 1 hour, 2 hours and 1 day after commencement of treatment
Secondary outcome [1] 9232 0
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] 9232 0
1 days after commencement of treatment and then at 3-monthly intervals for 12 months.
Secondary outcome [2] 9233 0
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] 9233 0
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
Gender
Both males and females
Can healthy volunteers participate?
No
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
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] 1594 0
China
State/province [1] 1594 0
Country [2] 1595 0
China
State/province [2] 1595 0
Guangdong province

Funding & Sponsors
Funding source category [1] 4711 0
Hospital
Name [1] 4711 0
State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center,Sun Yat-sen University
Address [1] 4711 0
54 South Xianlie Road, Guangzhou, Guangdong Province, 510060,china
Country [1] 4711 0
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] 4257 0
University
Name [1] 4257 0
Sun Yat-sen University
Address [1] 4257 0
135 West Xingang Road ,Guangzhou, Guangdong Province, 510275,china
Country [1] 4257 0
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 29309 0
Address 29309 0
Country 29309 0
Phone 29309 0
Fax 29309 0
Email 29309 0
Contact person for public queries
Name 12556 0
Wenru Su
Address 12556 0
54 South Xianlie Road, Guangzhou, Guangdong Province, 510060,china
Country 12556 0
China
Phone 12556 0
+86-20-13570364296
Fax 12556 0
Email 12556 0
swrth@163.com
Contact person for scientific queries
Name 3484 0
Wenru Su
Address 3484 0
54 South Xianlie Road, Guangzhou, Guangdong Province, 510060,china
Country 3484 0
China
Phone 3484 0
+86-20-13570364296
Fax 3484 0
Email 3484 0
swrth@163.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary