Back to resultsEfficacy And Safety of Pneumatic Trabeculoplasty
Primary Purpose
Primary Open Angle Glaucoma
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
"model 1000 PNT vacuum controller" (the vacuum device for ocular suction)
Sponsored by
About this trial
This is an interventional treatment trial for Primary Open Angle Glaucoma
Eligibility 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
Sites / Locations
- University "Magna Graecia"
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PNT treatment
Arm Description
all subjects enrolled in the study, that underwent PNT treatment
Outcomes
Primary Outcome Measures
intraocular pressure (IOP)
to evaluate one-year intraocular pressure (IOP) reduction after a standard pneumatic trabeculoplasty (PNT) treatment
Secondary Outcome Measures
Full Information
NCT ID
NCT01540331
First Posted
February 16, 2012
Last Updated
February 27, 2012
Sponsor
University of Catanzaro
1. Study Identification
Unique Protocol Identification Number
NCT01540331
Brief Title
Efficacy And Safety of Pneumatic Trabeculoplasty
Official Title
Phase 4 Study to Evaluate Efficacy And Safety of Pneumatic Trabeculoplasty (PNT) in Subjects Affected by Primary Open Angle Glaucoma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Catanzaro
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open Angle Glaucoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Care Provider
Allocation
N/A
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PNT treatment
Arm Type
Experimental
Arm Description
all subjects enrolled in the study, that underwent PNT treatment
Intervention Type
Device
Intervention Name(s)
"model 1000 PNT vacuum controller" (the vacuum device for ocular suction)
Other Intervention Name(s)
manifacturer: Ophthalmic International, Fountain Hills - AZ, USA
Intervention Description
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.
Primary Outcome Measure Information:
Title
intraocular pressure (IOP)
Description
to evaluate one-year intraocular pressure (IOP) reduction after a standard pneumatic trabeculoplasty (PNT) treatment
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luigi Varano, M. D.
Organizational Affiliation
University "Magna Graecia" of Catanzaro
Official's Role
Principal Investigator
Facility Information:
Facility Name
University "Magna Graecia"
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Efficacy And Safety of Pneumatic Trabeculoplasty
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