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180 Degree vs. 360 Degree Selective Laser Trabeculoplasty as Initial Therapy for Glaucoma

NCT ID: NCT02628223

Last Updated: 2020-11-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2017-12-31

Brief Summary

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Selective laser trabeculoplasty (SLT) is a well-recognized way to lower eye pressure in treatment of glaucoma. This treatment is performed for 180 degrees or 360 degrees, and studies at academic centers have shown mixed results when comparing the success rates of 180 degrees or 360 degrees. Both protocols are now typically done by comprehensive ophthalmologists. However, there is no data that compares success rates of 180 degrees and 360 degrees in the community setting.

Detailed Description

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This study is designed as a prospective evaluation of the two treatment algorithms for SLT by measuring intraocular pressure (IOP) after treatment. The hypothesis is that 360 degrees of SLT will produce a greater reduction in IOP than 180 degrees of SLT at 3 months follow up.

Conditions

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Open Angle Glaucoma Ocular Hypertension Glaucoma, Open Angle, Pseudo-exfoliative Pigment Dispersion Syndrome Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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180 degrees

180 degrees of Selective Laser Trabeculoplasty using Neodymium:Yttrium Aluminum Garnet (YAG) laser

Group Type ACTIVE_COMPARATOR

Selective Laser Trabeculoplasty

Intervention Type PROCEDURE

The procedure uses light energy provided by a neodymium (Nd):Yttrium Aluminum Garnet (YAG) laser that is directed into the iridocorneal angle via a goniolens viewed through a standard slit lamp.

Neodymium:Yttrium Aluminum Garnet (YAG) laser

Intervention Type DEVICE

The procedure uses a 400 μm spot size of light energy provided by a low-energy, Q-switched, frequency-doubled (532 nm) neodymium (Nd):Yttrium Aluminum Garnet (YAG) laser with a short pulse duration of 3 nanoseconds that is directed into the iridocorneal angle via a goniolens viewed through a standard slit lamp.

360 degrees

360 degrees of Selective Laser Trabeculoplasty using Neodymium:Yttrium Aluminum Garnet (YAG) laser

Group Type ACTIVE_COMPARATOR

Selective Laser Trabeculoplasty

Intervention Type PROCEDURE

The procedure uses light energy provided by a neodymium (Nd):Yttrium Aluminum Garnet (YAG) laser that is directed into the iridocorneal angle via a goniolens viewed through a standard slit lamp.

Neodymium:Yttrium Aluminum Garnet (YAG) laser

Intervention Type DEVICE

The procedure uses a 400 μm spot size of light energy provided by a low-energy, Q-switched, frequency-doubled (532 nm) neodymium (Nd):Yttrium Aluminum Garnet (YAG) laser with a short pulse duration of 3 nanoseconds that is directed into the iridocorneal angle via a goniolens viewed through a standard slit lamp.

Interventions

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Selective Laser Trabeculoplasty

The procedure uses light energy provided by a neodymium (Nd):Yttrium Aluminum Garnet (YAG) laser that is directed into the iridocorneal angle via a goniolens viewed through a standard slit lamp.

Intervention Type PROCEDURE

Neodymium:Yttrium Aluminum Garnet (YAG) laser

The procedure uses a 400 μm spot size of light energy provided by a low-energy, Q-switched, frequency-doubled (532 nm) neodymium (Nd):Yttrium Aluminum Garnet (YAG) laser with a short pulse duration of 3 nanoseconds that is directed into the iridocorneal angle via a goniolens viewed through a standard slit lamp.

Intervention Type DEVICE

Other Intervention Names

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SLT Nd:YAG laser

Eligibility Criteria

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Inclusion Criteria

* patients who have been diagnosed with open-angle glaucoma including ocular hypertension, pseudoexfoliation and pigment dispersion syndrome
* greater than 18 years of age
* initial intraocular pressure (IOP) of ≥ 21 mmHg

Exclusion Criteria

* prior medical or laser therapy to lower IOP
* previous incisional glaucoma surgery before the study period
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Temple University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeffrey D. Henderer, MD

Role: PRINCIPAL_INVESTIGATOR

Temple University

Sophia Siu, MD

Role: STUDY_DIRECTOR

Temple University

Locations

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Brandywine Eye Center

Wilmington, Delaware, United States

Site Status

Levin Luminais Chronister Eye Associates

Thorndale, Pennsylvania, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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21921

Identifier Type: -

Identifier Source: org_study_id