IOP Lowering Effect of PLT Versus SLT in Naiv OAG Patients

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2017-02-28

Brief Summary

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To investigate the effect of patterned laser trabeculoplasty (PLT) compared to selective laser trabeculoplasty (SLT) on intraocular pressure (IOP) in treatment naiv patients suffering from open-angle glaucoma or ocular hypertension.

Values for IOP will be measured at baseline, 1 day and 1 month post-interventional as well as 2, 3, 6, 9, 12, 18 and 24 months after treatment.

* Trial with medical device

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Detailed Description

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Conditions

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Open Angle Glaucoma, Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PLT

patients treated with patterned laser trabeculoplasty

Group Type EXPERIMENTAL

Laser trabeculoplasty

Intervention Type DEVICE

SLT

patients treated with selective laser trabeculoplasty

Group Type ACTIVE_COMPARATOR

Laser trabeculoplasty

Intervention Type DEVICE

Interventions

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Laser trabeculoplasty

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Intraocular pressure (treatment naiv or after 4 weeks wash-out phase) \> 21 mm Hg
* visible angle structures over 360° on gonioscopy
* age = 18 years

Exclusion Criteria

* Intraocular Inflammation
* patients who underwent refractive corneal surgery for any reason or who underwent ocular surgery to reduce intraocular pressure (e.g. trabeculectomy)
* monocle situation
* anterior chamber lenses (incl. iris claw)
* secondary glaucoma (with the exception of pseudoexfoliation and pigment dispersion)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No