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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.
Register: ISRCTN
Last refreshed on: 12 February 2013
Main ID:  ISRCTN79745214
Date of registration: 20/03/2008
Primary sponsor: University of Bologna (Italy)
Public title: Matrix metalloproteinases and their tissue inhibitors after selective laser trabeculoplasty in pseudoexfoliative secondary glaucoma N/A
Scientific title:
Date of first enrolment: Feb 13 2006
Target sample size: 45
Recruitment status: Completed/Not recruiting
URL:  http://isrctn.org/ISRCTN79745214
Study type:  Observational
Study design:  Observational, open, single centre, case-control study  
Countries of recruitment
Italy
Contacts
Name: Mauro  Cellini
Address:  Via Massarenti, 9 40138 Bologna Italy
Telephone:
Email:
Affiliation: 
Key inclusion & exclusion criteria
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:
Health Condition(s) or Problem(s) studied
Pseudoexfoliative secondary glaucoma
Intervention(s)
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.
Primary Outcome(s)
MMP-2 and TIMP-2 concentration, assessed once during the cataract surgery in Arm 1 and 3, and during trabeculectomy in Arm 2.
Secondary Outcome(s)
Intraocular pressure, measured before surgery and 7, 15 days and one month after surgery in all three arms of participants.
Secondary ID(s)
N/A
Source(s) of Monetary Support
St Orsola Malpighi University Hospital Bologna (Italy)
Secondary Sponsor(s)
N/A
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