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ISRCTN
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ISRCTN79745214
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ClinicalTrials.gov identifier
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Public title
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Matrix metalloproteinases and their tissue inhibitors after selective laser trabeculoplasty in pseudoexfoliative secondary glaucoma
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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Pseudoexfoliative glaucoma (PEXG) is a degenerative fibrillopathy characterised by the production and accumulation of extracellular fibrillar material not just in the anterior segment of the eye, but also in numerous extraocular tissues. At an ocular level, there is atrophy of the iris dilator muscle fibre cells, degeneration of the irideal pigment with dispersion of melanin, peripupillar atrophy and an increase in the trabecular meshwork pigmentation. A typical feature is the excessive accumulation of the extracellular matrix material in the juxtacanalicular tissue. This accumulation explains the increased resistance to aqueous outflow found in eyes with PEXG.
Study aim:
To assess the variations in the metalloproteinases (MMP-2) and tissue inhibitor of metalloproteinases (TIMP-2) values following selective laser trabeculoplasty (SLT) in patients with pseudoexfoliative glaucoma (PEXG).
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Ethics approval
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Ethics approval received from the Institutional Ethics Committee of the St Orsola Malpighi University Hospital, University of Bologna on the 24th October 2007 (ref: 2007-007744-98).
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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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Disease/condition/study domain
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Pseudoexfoliative secondary glaucoma
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Participants - inclusion criteria
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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)
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Participants - exclusion criteria
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1. Pseudophachia
2. Non-pseudoexfoliative glaucoma
3. History of laser treatment
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Anticipated start date
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13/02/2006
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Anticipated end date
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15/06/2006
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Status of trial
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Completed
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Patient information material
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Target number of participants
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45
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Interventions
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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 measure(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 measure(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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Sources of funding
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St Orsola Malpighi University Hospital Bologna (Italy)
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Trial website
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Publications
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Contact name
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Dr
Mauro
Cellini
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Address
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Via Massarenti, 9
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City/town
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Bologna
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Zip/Postcode
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40138
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Country
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Italy
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Sponsor
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University of Bologna (Italy)
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Address
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Department of Surgery and Anaesthesiology Science
Ophthalmology Service
Via Massarenti, 9
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City/town
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Bologna
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Zip/Postcode
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40139
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Country
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Italy
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Sponsor website:
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http://www.eng.unibo.it/PortaleEn
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Date applied
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13/03/2008
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Last edited
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25/03/2008
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Date ISRCTN assigned
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20/03/2008
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