Primary Open Angle Glaucoma
Conditions
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
Interventions
DEVICEmodel 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.
Sponsors
University of Catanzaro
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Italy
Outcome results
None listed