Efficacy And Safety of Pneumatic Trabeculoplasty

University of Catanzaro27 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Primary Open Angle Glaucoma

Interventions

"model 1000 PNT vacuum controller" (the vacuum device for ocular suction)DEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University "Magna Graecia"

Catanzaro, Italy

Outcomes

Primary Outcomes

intraocular pressure (IOP)

to evaluate one-year intraocular pressure (IOP) reduction after a standard pneumatic trabeculoplasty (PNT) treatment

Time frame: 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)

Data from ClinicalTrials.gov

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