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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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12 February 2013 |
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Main ID: |
ISRCTN79745214 |
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Date of registration:
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20/03/2008 |
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Primary sponsor: |
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Public title:
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Matrix metalloproteinases and their tissue inhibitors after selective laser trabeculoplasty in pseudoexfoliative secondary glaucoma
N/A |
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Scientific title:
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Date of first enrolment:
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Feb 13 2006 |
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Target sample size:
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45 |
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Recruitment status: |
Completed/Not recruiting |
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URL:
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http://isrctn.org/ISRCTN79745214 |
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Study type:
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Observational |
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Study design:
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Observational, open, single centre, case-control study
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Countries of recruitment
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Italy
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Contacts
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Name:
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Mauro
Cellini |
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Address:
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Via Massarenti, 9
40138
Bologna
Italy |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Fifteen patients with pseudoexfoliative glaucoma and cataract, and 15 patients with pseudoexfoliative glaucoma (30 patients in total):
1. Patients of either gender
2. Aged from 58 - 74 (in all three arms)
Exclusion criteria: 1. Pseudophachia
2. Non-pseudoexfoliative glaucoma
3. History of laser treatment
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Pseudoexfoliative secondary glaucoma
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Intervention(s)
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Arm 1: Patients with pseudoexfoliative glaucoma with good intraocular eye pressure (IOP) control and cataract (15 patients). These patients received cataract surgery only.
Arm 2: Patients with pseudoexfoliative glaucoma only that undewent selective laser trabeculoplasy (SLT) without good control of IOP (15 patients). These patients received SLT, and after one month surgical trabeculectomy.
Arm 3 (control group): Patients with catarct only (15 patients). These patients received catarct surgery only.
Selective laser trabeculoplasty (SLT) was performed with Selecta 7000 (Q switched, frequency doubled, 532 Nd:YAG laser) using 50 non-overlapping applications in the inferior 180° of the trabecular meshwork, with a spot size of 400 µm and pulse duration of 3 ns. Aqueous humour was aspirated during surgery from patients.
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Primary Outcome(s)
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MMP-2 and TIMP-2 concentration, assessed once during the cataract surgery in Arm 1 and 3, and during trabeculectomy in Arm 2.
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Secondary Outcome(s)
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Intraocular pressure, measured before surgery and 7, 15 days and one month after surgery in all three arms of participants.
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Source(s) of Monetary Support
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St Orsola Malpighi University Hospital Bologna (Italy)
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