Efficacy And Safety of Pneumatic Trabeculoplasty

Study Overview
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Brief Summary
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The purpose of this study is to evaluate prospectively the PNT safety and efficacy in term of IOP reduction in a group of previously or newly diagnosed glaucomatous subjects.

Detailed Description
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A group of subjects affected by Primary Open Angle Glaucoma (POAG) underwent 3 PNT treatments to evaluate one-year efficacy in term of IOP reduction and one-year safety in term of incidence of adverse events

Official Title
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Phase 4 Study to Evaluate Efficacy And Safety of Pneumatic Trabeculoplasty (PNT) in Subjects Affected by Primary Open Angle Glaucoma

Conditions
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Primary Open Angle Glaucoma

Intervention / Treatment
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* Device: model 1000 PNT vacuum controller (the vacuum device for ocular suction)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects affected by primary open angle glaucoma Exclusion Criteria: Any local or systemic contraindication to timolol topical therapy Chronic iritis and/or uveitis in one or both eyes, History of inflammatory glaucoma, Hemorrhagic glaucoma, Post-traumatic glaucoma, Phacolytic glaucoma, Acute glaucomatocyclitic attack, Closed angle/narrow angle glaucoma in one or both eyes, Previous corneal transplantation, Proliferative diabetic retinopathy with/without iris neovascularisation, Significative disk cupping (90% of complete disk area), Large and severe perimetric defects (I. e. a central perimetric residual not above 10 central degrees), Dry/wet age related macular degeneration in one or both eyes, Previous glaucoma surgery (Laser therapy was not considered) Keratitis Severe dry eye disease, Corneal dystrophies High myopia (more than 6 dioptres) Peripheral retinal degenerations with risk of retinal detachment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PNT treatment<br>all subjects enrolled in the study, that underwent PNT treatment | Device: model 1000 PNT vacuum controller (the vacuum device for ocular suction)<br>* A Pneumatic Trabeculoplasty treatment, composed of 3 single PNT applications at day 0, 7 and 90. Each treatment consist in a ocular pneumatic suction of 500inchHg administered for 60 seconds in perilimbal region through the device (model 1000 PNT vacuum controller). This suction is then repeated after a 5 minutes pause.<br>* Other names: manifacturer: Ophthalmic International, Fountain Hills - AZ, USA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraocular pressure (IOP) | to evaluate one-year intraocular pressure (IOP) reduction after a standard pneumatic trabeculoplasty (PNT) treatment | Patients will be followed for one year. Time-points:recruitment, Basal (30 days after recruitment), Follow-Up2 (30 days after basal), Follow-Up3 (3 months after basal), Follow-Up4 (6 months after basal), Follow-Up5 (one year after basal) |