Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
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).
Ethics approval
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).
Study design
Observational, open, single centre, case-control study
Primary study design
Observational
Secondary study design
Case-control study
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Pseudoexfoliative secondary glaucoma
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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 measures
Intraocular pressure, measured before surgery and 7, 15 days and one month after surgery in all three arms of participants.
Overall trial start date
13/02/2006
Overall trial end date
15/06/2006
Reason abandoned
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
45
Participant exclusion criteria
1. Pseudophachia
2. Non-pseudoexfoliative glaucoma
3. History of laser treatment
Recruitment start date
13/02/2006
Recruitment end date
15/06/2006
Locations
Countries of recruitment
Italy
Trial participating centre
Via Massarenti, 9
Bologna
40138
Italy
Sponsor information
Organisation
University of Bologna (Italy)
Sponsor details
Department of Surgery and Anaesthesiology Science
Ophthalmology Service
Via Massarenti
9
Bologna
40139
Italy
Sponsor type
University/education
Website
Funders
Funder type
Hospital/treatment centre
Funder name
St Orsola Malpighi University Hospital Bologna (Italy)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary