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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Eye Diseases
Ocular Hypertension

ClinicalTrials.gov processed this record on November 20, 2014