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Efficacy And Safety of Pneumatic Trabeculoplasty

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Luigi Varano, MD, University of Cantanzaro
ClinicalTrials.gov Identifier:
NCT01540331
First received: February 16, 2012
Last updated: February 27, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Primary Open Angle Glaucoma
 Device: "model 1000 PNT vacuum controller" (the vacuum device for ocular suction)
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Official Title: Phase 4 Study to Evaluate Efficacy And Safety of Pneumatic Trabeculoplasty (PNT) in Subjects Affected by Primary Open Angle Glaucoma

Resource links provided by NLM:

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Further study details as provided by University of Cantanzaro:

Primary Outcome 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) ] [ Designated as safety issue: Yes ]
    to evaluate one-year intraocular pressure (IOP) reduction after a standard pneumatic trabeculoplasty (PNT) treatment


Enrollment: 27
Study Start Date: June 2009
Study Completion Date: January 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: manifacturer: Ophthalmic International, Fountain Hills - AZ, USA

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01540331

Locations
Italy
University "Magna Graecia"
Catanzaro, Italy, 88100
Sponsors and Collaborators
University of Cantanzaro
Investigators
Principal Investigator: Luigi Varano, M. D. University "Magna Graecia" of Catanzaro
  More Information

No publications provided

Responsible Party: Luigi Varano, MD, M. D., University of Cantanzaro
ClinicalTrials.gov Identifier: NCT01540331     History of Changes
Other Study ID Numbers: PNT01
Study First Received: February 16, 2012
Last Updated: February 27, 2012
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on June 17, 2013