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ISRCTN
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ISRCTN45213099
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ClinicalTrials.gov identifier
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Public title
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Zhongshan angle-closure prevention study
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Scientific title
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A randomised controlled trial of prevention of angle-closure glaucoma in China
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Acronym
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ZAAP
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Serial number at source
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1
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Study hypothesis
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That laser iridotomy helps to prevent primary angle-closure (a major risk factor for glaucoma) in Chinese adults aged 50 years and older.
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Ethics approval
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Ethics approval received from:
1. Ethical Review Board of Zhongshan Ophthalmic Centre (China) in November 2002
2. London School of Hygiene and Tropical Medicine (UK) on the 17th March 2008 (ref: 5267)
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Study design
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Single-centre, randomised, controlled trial (not masked)
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Countries of recruitment
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China
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Disease/condition/study domain
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Angle-closure glaucoma
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Participants - inclusion criteria
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1. Anatomically narrow drainage angles in the anterior segment of the eye
2. No evidence of primary angle-closure (high pressure or peripheral anterior synechiae)
3. Aged greater than or equal to 50 years
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Participants - exclusion criteria
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1. Inability or unwillingness to give informed consent
2. Raised intraocular pressure, peripheral anterior synechiae or glaucomatous optic neuropathy
3. Previous intraocular surgery
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Anticipated start date
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01/03/2008
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Anticipated end date
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28/02/2011
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Status of trial
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Ongoing
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet (available in Chinese with English translation upon request)
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Target number of participants
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1,100
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Interventions
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The right and left eyes of each participant will be randomly allocated to the intervention treatment or no treatment (control).
Intervention treatment: Laser iridotomy by sequential argon then Nd:YAG laser. Duration of the laser treatment is about 5 minutes.
Control: No intervention (current standard treatment only)
Each participant will be examined at baseline, 2 weeks, 6, 18, 30 and 42 months.
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Primary outcome measure(s)
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The following will be assessed on each of the scheduled follow-up (6, 18, 30 and 42 months):
1. Raised intraocular pressure (either with or without symptoms). Intraocular pressure greater than 24 mmHg verified on two consecutive measurements on separate days. These patients will be further identified as having open, partially-closed or completely closed angles on dark room gonioscopy and anterior segment optical coherence tomography (AS-OCT).
2. Peripheral anterior synechiae
3. Glaucomatous optic neuropathy
If participants are felt to have met a failure criterion, we will re-assess (by examination with one of the senior investigators) within the next 2 weeks to confirm. The failure will then be classified as having occurred at 6, 18, 30 or 42 months (end of the study).
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Secondary outcome measure(s)
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The following will be assessed on each of the scheduled follow-up (6, 18, 30 and 42 months):
1. Specular microscopy measures of corneal endothelial cell loss
2. Formation of lens opacity
3. Anterior segment optical coherence tomography measures (qualitative and quantitative) of ocular anterior segment anatomy
If participants are felt to have met a failure criterion, we will re-assess (by examination with one of the senior investigators) within the next 2 weeks to confirm. The failure will then be classified as having occurred at 6, 18, 30 or 42 months (end of the study).
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Sources of funding
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1. Fight for Sight (UK) - Project grant
2. Sun Yat-Sen University (China) - Clinical Research 5010 (ref: 2007033)
3. Ministry of Education (China) - Programme Grant for Outstanding University Researchers (ref: NCET 06 0720)
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Trial website
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Publications
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Contact name
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Dr
Paul
Foster
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Address
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University College London
Institute of Ophthalmology
11-43 Bath Street
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City/town
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London
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Zip/Postcode
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EC1V 9EL
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Country
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United Kingdom
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Tel
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+44 (0)20 7608 6899
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Fax
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+44 (0)20 7608 4012
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Email
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p.foste@ucl.ac.uk
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Sponsor
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University College London (UK)
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Address
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Gower Street
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City/town
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London
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Zip/Postcode
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WC1E 6BT
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Country
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United Kingdom
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Tel
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+44 (0)20 7608 6854
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Fax
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+44 (0)20 7608 6954
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Email
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h.jones@ucl.ac.uk
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Sponsor website:
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http://www.ucl.ac.uk/
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Date applied
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16/01/2008
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Last edited
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06/05/2008
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Date ISRCTN assigned
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06/05/2008
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