Efficacy And Safety of Pneumatic Trabeculoplasty

University of Catanzaro

Status and phase: Completed; Phase 4

Conditions: Primary Open Angle Glaucoma

Treatments: Device: "model 1000 PNT vacuum controller" (the vacuum device for ocular suction)

Study type: Interventional

Funder types: Other

Identifiers

NCT01540331

PNT01

Details and patient eligibility

About

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.

Full 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

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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27 participants in 1 patient group

PNT treatment

Experimental group

Description:

all subjects enrolled in the study, that underwent PNT treatment

Treatment:

Device: "model 1000 PNT vacuum controller" (the vacuum device for ocular suction)