Efficacy And Safety of Pneumatic Trabeculoplasty

Primary Open Angle Glaucoma Clinical Trial

Official title:

Phase 4 Study to Evaluate Efficacy And Safety of Pneumatic Trabeculoplasty (PNT) in Subjects Affected by Primary Open Angle Glaucoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01540331
• Other study ID #: PNT01
• Status: Completed
• Phase: Phase 4
• First received: February 16, 2012
• Last updated: February 27, 2012
• Start date: June 2009
• Est. completion date: January 2012

Study information

• Verified date: February 2012
• Source: University of Cantanzaro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: January 2012
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Primary Open Angle Glaucoma

Intervention

Device:
• "model 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.

Locations

Country	Name	City	State
Italy	University "Magna Graecia"	Catanzaro

Sponsors (1)

Lead Sponsor	Collaborator
University of Cantanzaro

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes