Efficacy And Safety of Pneumatic Trabeculoplasty

February 27, 2012 updated by: Luigi Varano, MD, University of Catanzaro

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Catanzaro, Italy, 88100
        • University "Magna Graecia"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PNT treatment
all subjects enrolled in the study, that underwent PNT treatment
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.
Other Names:
  • manifacturer: Ophthalmic International, Fountain Hills - AZ, USA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Catanzaro

Investigators

  • Principal Investigator: Luigi Varano, M. D., University "Magna Graecia" of Catanzaro

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

February 16, 2012

First Submitted That Met QC Criteria

February 27, 2012

First Posted (Estimate)

February 28, 2012

Study Record Updates

Last Update Posted (Estimate)

February 28, 2012

Last Update Submitted That Met QC Criteria

February 27, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PNT01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Primary Open Angle Glaucoma

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe