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Efficacy And Safety of Pneumatic Trabeculoplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01540331
Recruitment Status : Completed
First Posted : February 28, 2012
Last Update Posted : February 28, 2012
Sponsor:
Information provided by (Responsible Party):
Luigi Varano, MD, University of Catanzaro

Brief Summary:
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 or disease Intervention/treatment Phase
Primary Open Angle Glaucoma Device: "model 1000 PNT vacuum controller" (the vacuum device for ocular suction) Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Care Provider)
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
Study Start Date : June 2009
Actual Primary Completion Date : June 2011
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

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 Name: manifacturer: Ophthalmic International, Fountain Hills - AZ, USA




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01540331


Locations
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Italy
University "Magna Graecia"
Catanzaro, Italy, 88100
Sponsors and Collaborators
University of Catanzaro
Investigators
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Principal Investigator: Luigi Varano, M. D. University "Magna Graecia" of Catanzaro
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Responsible Party: Luigi Varano, MD, M. D., University of Catanzaro
ClinicalTrials.gov Identifier: NCT01540331    
Other Study ID Numbers: PNT01
First Posted: February 28, 2012    Key Record Dates
Last Update Posted: February 28, 2012
Last Verified: February 2012
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases