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OpenTrials
Completed

NCT Number: NCT02628223

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brandywine Eye Center, Wilmington, Delaware, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Selective Laser Trabeculoplasty

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.

Other names: SLT

Neodymium:Yttrium Aluminum Garnet (YAG) laser

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.

Other names: Nd:YAG laser

Primary outcomes

  1. Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at Three Months of Follow-up

    Time frame: 3 months

    Intraocular pressure (IOP) measured by tonometry in millimeters of mercury at three months of follow-up

Secondary outcomes

  1. Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at 1 Year of Follow-up

    Time frame: 1 year

    Intraocular pressure (IOP) measured by tonometry in millimeters of mercury at 1 year of follow-up

  2. Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at Time at Which Additional Glaucoma Therapy is Required

    Time frame: within 1 year of study intervention

    Intraocular pressure (IOP) measured by tonometry in millimeters of mercury at time at which additional glaucoma therapy is required

  3. Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at Last Follow-up

    Time frame: within 1 year of study intervention

    Intraocular pressure (IOP) measured by tonometry in millimeters of mercury at last follow-up

Other outcomes

  1. Number of Participants With Intraocular Pressure (IOP) Spike Assessed by Tonometry

    Time frame: within 1 year of study intervention

    If IOP spike occurs, it will be treated accordingly.

  2. Number of Participants With Trabeculitis Assessed by Ophthalmic Exam and Gonioscopy

    Time frame: within 1 year of study intervention

    If trabeculitis occurs, it will be treated accordingly.

Sponsors and collaborators

Lead sponsor

Temple University

Other

Registry information

Official study title

A Randomized Trial of 180 Degree vs. 360 Degree Selective Laser Trabeculoplasty as Initial Therapy for Glaucoma

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Dec 11, 2015
Registry last updated
Nov 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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