Efficacy And Safety of Pneumatic Trabeculoplasty
Phase 4 Study to Evaluate Efficacy And Safety of Pneumatic Trabeculoplasty (PNT) in Subjects Affected by Primary Open Angle Glaucoma
1 other identifier
interventional
27
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jun 2009
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 16, 2012
CompletedFirst Posted
Study publicly available on registry
February 28, 2012
CompletedFebruary 28, 2012
February 1, 2012
2 years
February 16, 2012
February 27, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
intraocular pressure (IOP)
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)
Study Arms (1)
PNT treatment
EXPERIMENTALall subjects enrolled in the study, that underwent PNT treatment
Interventions
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.
Eligibility Criteria
You may qualify if:
- Subjects affected by primary open angle glaucoma
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University "Magna Graecia"
Catanzaro, 88100, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Luigi Varano, M. D.
University "Magna Graecia" of Catanzaro
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M. D.
Study Record Dates
First Submitted
February 16, 2012
First Posted
February 28, 2012
Study Start
June 1, 2009
Primary Completion
June 1, 2011
Study Completion
January 1, 2012
Last Updated
February 28, 2012
Record last verified: 2012-02