Condition category
Eye Diseases
Date applied
13/03/2008
Date assigned
20/03/2008
Last edited
25/03/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mauro Cellini

ORCID ID

Contact details

Via Massarenti
9
Bologna
40138
Italy

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

http://www.eng.unibo.it/PortaleEn

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

Publication citations

Additional files

Editorial Notes