An interventional study of Micropulse laser trabeculoplasty in Pseudoexfoliation Glaucoma and Primary Open-angle Glaucoma, sponsored by University Hospital of Patras. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-04.
Sponsored by University Hospital of Patras · Not applicable, Interventional, and Treatment
This study aims to evaluate the effect of a single session of micropulse laser trabeculoplasty (MLT) on cornea in eyes with primary open glaucoma (POAG) and pseudoexfoliation glaucoma (PEXG).
Patients with PEXG under prostaglandine analogue monotherapy with inadequate IOP control are treated with 360-degrees 532nm MLT.
Patients are evaluated at 1 day, 1 month, 3 months, 6 months and 12 months post-MLT. After trabeculoplasty patients are maintained in treatment with the same drug regimen as pre-MLT.
72 studies on the registry are indexed under Exfoliation Syndrome; 20 are open to participants now.
This study's enrollment of 27 is below the median of 64 across 34 interventional studies indexed under Exfoliation Syndrome.
Browse Exfoliation Syndrome studies →University Hospital of Patras is the lead sponsor of 43 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with pseudoexfoliation glaucoma (PEXG) under prostaglandine analogue monotherapy with inadequate IOP control treated with 360-degrees 532nm micropulse laser trabeculoplasty (MLT)
Procedure: Micropulse laser trabeculoplasty
Micropulse laser trabeculoplasty is performed using the Iridex IQ 532 laser system (Iridex Corporation, 1212 Terra Bella Avenue, Mountain View, CA, USA) and 532 nm (green) wavelength MLT is applied with confluent applications to pigmented trabecular meshwork over 360 degrees using a 300 µm spot size, 300 ms duration, 1000 mW power and 15% duty cycle.
Also known as: MLT Iridex IQ 532 laser system
Intraocular Pressure
The change in IOP at 12 months versus baseline and the percentage of patients with ≥20% reduction in IOP.
Time frame: 12 months
Intraocular Pressure
Change in IOP and the percentage of ≥20% IOP reduction at 1, 3 and 6 months after MLT
Time frame: 1, 3 and 6 months
No study locations are listed for this record.
Ran from Dec 2016 to primary completion in Mar 2018, 15 months.
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This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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University Hospital of Patras