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Completed

NCT Number: NCT01540331

Efficacy And Safety of Pneumatic Trabeculoplasty

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.

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Key information

Conditions

Primary Open Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University "Magna Graecia"

Catanzaro, 88100, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

"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.

Other names: manifacturer: Ophthalmic International, Fountain Hills - AZ, USA

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Catanzaro

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Feb 28, 2012
Registry last updated
Feb 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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