Efficacy And Safety of Pneumatic Trabeculoplasty
Phase 4
Completed
- Conditions
- Primary Open Angle Glaucoma
- Interventions
- Device: "model 1000 PNT vacuum controller" (the vacuum device for ocular suction)
- Registration Number
- NCT01540331
- Lead Sponsor
- 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.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 27
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PNT treatment "model 1000 PNT vacuum controller" (the vacuum device for ocular suction) all subjects enrolled in the study, that underwent PNT treatment
- Primary Outcome Measures
Name Time Method intraocular pressure (IOP) 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University "Magna Graecia"
🇮🇹Catanzaro, Italy