Matrix metalloproteinases and their tissue inhibitors after selective laser trabeculoplasty in pseudoexfoliative secondary glaucoma
| ISRCTN | ISRCTN79745214 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79745214 |
| Protocol serial number | N/A |
| Sponsor | University of Bologna (Italy) |
| Funder | St Orsola Malpighi University Hospital Bologna (Italy) |
- 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
Scientific
Via Massarenti, 9
Bologna
40138
Italy
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational, open, single centre, case-control study |
| Secondary study design | Case-control study |
| Scientific title | Matrix metalloproteinases and their tissue inhibitors after selective laser trabeculoplasty in pseudoexfoliative secondary glaucoma |
| Study objectives | 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(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) studied | 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 |
| Primary outcome measure(s) |
MMP-2 and TIMP-2 concentration, assessed once during the cataract surgery in Arm 1 and 3, and during trabeculectomy in Arm 2. |
| Key secondary outcome measure(s) |
Intraocular pressure, measured before surgery and 7, 15 days and one month after surgery in all three arms of participants. |
| Completion date | 15/06/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 45 |
| Total final enrolment | 30 |
| Key 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) |
| Key exclusion criteria | 1. Pseudophachia 2. Non-pseudoexfoliative glaucoma 3. History of laser treatment |
| Date of first enrolment | 13/02/2006 |
| Date of final enrolment | 15/06/2006 |
Locations
Countries of recruitment
- Italy
Study participating centre
Via Massarenti, 9
Bologna
40138
Italy
40138
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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.
