Efficacy And Safety of Pneumatic Trabeculoplasty

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Care Provider)
  • Study Primary Completion Date: June 2011

Detailed Description

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

Interventions

  • Device: “model 1000 PNT vacuum controller” (the vacuum device for ocular suction)
    • 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.

Arms, Groups and Cohorts

  • Experimental: PNT treatment
    • all subjects enrolled in the study, that underwent PNT treatment

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Catanzaro
  • Provider of Information About this Clinical Study
    • Principal Investigator: Luigi Varano, MD, M. D. – University of Catanzaro
  • Overall Official(s)
    • Luigi Varano, M. D., Principal Investigator, University “Magna Graecia” of Catanzaro

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