Matrix metalloproteinases and their tissue inhibitors after selective laser trabeculoplasty in pseudoexfoliative secondary glaucoma

ISRCTN ISRCTN79745214
DOI https://doi.org/10.1186/ISRCTN79745214
Secondary identifying numbers N/A
Submission date
13/03/2008
Registration date
20/03/2008
Last edited
30/12/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Mauro Cellini
Scientific

Via Massarenti, 9
Bologna
40138
Italy

Study information

Study designObservational, open, single centre, case-control study
Primary study designObservational
Secondary study designCase-control study
Study setting(s)Not specified
Study typeTreatment
Scientific titleMatrix metalloproteinases and their tissue inhibitors after selective laser trabeculoplasty in pseudoexfoliative secondary glaucoma
Study objectivesPseudoexfoliative 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(s)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).
Health condition(s) or problem(s) studiedPseudoexfoliative secondary glaucoma
InterventionArm 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 typeOther
Primary outcome measureMMP-2 and TIMP-2 concentration, assessed once during the cataract surgery in Arm 1 and 3, and during trabeculectomy in Arm 2.
Secondary outcome measuresIntraocular pressure, measured before surgery and 7, 15 days and one month after surgery in all three arms of participants.
Overall study start date13/02/2006
Completion date15/06/2006

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants45
Total final enrolment30
Key inclusion criteriaFifteen 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)
Key exclusion criteria1. Pseudophachia
2. Non-pseudoexfoliative glaucoma
3. History of laser treatment
Date of first enrolment13/02/2006
Date of final enrolment15/06/2006

Locations

Countries of recruitment

  • Italy

Study participating centre

Via Massarenti, 9
Bologna
40138
Italy

Sponsor information

University of Bologna (Italy)
University/education

Department of Surgery and Anaesthesiology Science
Ophthalmology Service
Via Massarenti, 9
Bologna
40139
Italy

Website http://www.eng.unibo.it/PortaleEn
ROR logo "ROR" https://ror.org/01111rn36

Funders

Funder type

Hospital/treatment centre

St Orsola Malpighi University Hospital Bologna (Italy)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 21/10/2008 30/12/2020 Yes No

Editorial Notes

30/12/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.