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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01540331
Other study ID # PNT01
Secondary ID
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


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
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