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Efficacy And Safety of Pneumatic Trabeculoplasty

NCT ID: NCT01540331

Last Updated: 2012-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2012-01-31

Brief Summary

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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

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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

Conditions

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Primary Open Angle Glaucoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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PNT treatment

all subjects enrolled in the study, that underwent PNT treatment

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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.

Interventions

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"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.

Intervention Type DEVICE

Other Intervention Names

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manifacturer: Ophthalmic International, Fountain Hills - AZ, USA

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Catanzaro

OTHER

Sponsor Role lead

Responsible Party

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Luigi Varano, MD

M. D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Luigi Varano, M. D.

Role: PRINCIPAL_INVESTIGATOR

University "Magna Graecia" of Catanzaro

Locations

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University "Magna Graecia"

Catanzaro, , Italy

Site Status

Countries

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Italy

Other Identifiers

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PNT01

Identifier Type: -

Identifier Source: org_study_id