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

Sponsor
Temple University (Other)
Overall Status
Completed
CT.gov ID
NCT02628223
Collaborator
(none)
76
2
2
39
38
1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Selective Laser Trabeculoplasty
  • Device: Neodymium:Yttrium Aluminum Garnet (YAG) laser
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
76 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized Trial of 180 Degree vs. 360 Degree Selective Laser Trabeculoplasty as Initial Therapy for Glaucoma
Study Start Date :
Sep 1, 2014
Actual Primary Completion Date :
Dec 1, 2017
Actual Study Completion Date :
Dec 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 180 degrees

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

Procedure: 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.
Other Names:
  • SLT
  • Device: 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.
    Other Names:
  • Nd:YAG laser
  • Active Comparator: 360 degrees

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

    Procedure: 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.
    Other Names:
  • SLT
  • Device: 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.
    Other Names:
  • Nd:YAG laser
  • Outcome Measures

    Primary Outcome Measures

    1. Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at Three Months of Follow-up [3 months]

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

    Secondary Outcome Measures

    1. Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at 1 Year of Follow-up [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 [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 [within 1 year of study intervention]

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

    Other Outcome Measures

    1. Number of Participants With Intraocular Pressure (IOP) Spike Assessed by Tonometry [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 [within 1 year of study intervention]

      If trabeculitis occurs, it will be treated accordingly.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Brandywine Eye Center Wilmington Delaware United States 19810
    2 Levin Luminais Chronister Eye Associates Thorndale Pennsylvania United States 19372

    Sponsors and Collaborators

    • Temple University

    Investigators

    • Principal Investigator: Jeffrey D. Henderer, MD, Temple University
    • Study Director: Sophia Siu, MD, Temple University

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Temple University
    ClinicalTrials.gov Identifier:
    NCT02628223
    Other Study ID Numbers:
    • 21921
    First Posted:
    Dec 11, 2015
    Last Update Posted:
    Nov 5, 2020
    Last Verified:
    Nov 1, 2020

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title 180 Degrees 360 Degrees
    Arm/Group Description 180 degrees of Selective Laser Trabeculoplasty using Neodymium:Yttrium Aluminum Garnet (YAG) laser 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. 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. 360 degrees of Selective Laser Trabeculoplasty using Neodymium:Yttrium Aluminum Garnet (YAG) laser 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. 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.
    Period Title: Overall Study
    STARTED 38 38
    COMPLETED 38 36
    NOT COMPLETED 0 2

    Baseline Characteristics

    Arm/Group Title 180 Degrees 360 Degrees Total
    Arm/Group Description 180 degrees of Selective Laser Trabeculoplasty using Neodymium:Yttrium Aluminum Garnet (YAG) laser 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. 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. 360 degrees of Selective Laser Trabeculoplasty using Neodymium:Yttrium Aluminum Garnet (YAG) laser 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. 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. Total of all reporting groups
    Overall Participants 38 38 76
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    9
    23.7%
    5
    13.2%
    14
    18.4%
    >=65 years
    29
    76.3%
    33
    86.8%
    62
    81.6%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    71.4
    (8.6)
    71.9
    (6.7)
    71.6
    (7.7)
    Sex: Female, Male (Count of Participants)
    Female
    19
    50%
    20
    52.6%
    39
    51.3%
    Male
    19
    50%
    18
    47.4%
    37
    48.7%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    0
    0%
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    4
    10.5%
    8
    21.1%
    12
    15.8%
    White
    32
    84.2%
    28
    73.7%
    60
    78.9%
    More than one race
    1
    2.6%
    2
    5.3%
    3
    3.9%
    Unknown or Not Reported
    1
    2.6%
    0
    0%
    1
    1.3%
    Hypertension (Count of Participants)
    Count of Participants [Participants]
    25
    65.8%
    29
    76.3%
    54
    71.1%
    Diabetes (Count of Participants)
    Count of Participants [Participants]
    9
    23.7%
    14
    36.8%
    23
    30.3%
    Glaucoma (mild, moderate, severe, indeterminant) (Count of Participants)
    Mild
    13
    34.2%
    12
    31.6%
    25
    32.9%
    Moderate
    4
    10.5%
    8
    21.1%
    12
    15.8%
    Severe
    1
    2.6%
    2
    5.3%
    3
    3.9%
    Indeterminant
    7
    18.4%
    0
    0%
    7
    9.2%
    No Glaucoma
    13
    34.2%
    16
    42.1%
    29
    38.2%
    Ocular Hypertension (Count of Participants)
    Count of Participants [Participants]
    8
    21.1%
    12
    31.6%
    20
    26.3%
    Pseudoexfoliation (Count of Participants)
    Count of Participants [Participants]
    6
    15.8%
    1
    2.6%
    7
    9.2%
    Pigment Dispersion Syndrome (Count of Participants)
    Count of Participants [Participants]
    0
    0%
    0
    0%
    0
    0%

    Outcome Measures

    1. Primary Outcome
    Title Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at Three Months of Follow-up
    Description Intraocular pressure (IOP) measured by tonometry in millimeters of mercury at three months of follow-up
    Time Frame 3 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title 180 Degrees 360 Degrees
    Arm/Group Description 180 degrees of Selective Laser Trabeculoplasty using Neodymium:Yttrium Aluminum Garnet (YAG) laser 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. 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. 360 degrees of Selective Laser Trabeculoplasty using Neodymium:Yttrium Aluminum Garnet (YAG) laser 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. 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.
    Measure Participants 38 36
    Mean (Standard Deviation) [mm Hg]
    20.7
    (5.4)
    19.1
    (4.1)
    2. Secondary Outcome
    Title Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at 1 Year of Follow-up
    Description Intraocular pressure (IOP) measured by tonometry in millimeters of mercury at 1 year of follow-up
    Time Frame 1 year

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title 180 Degrees 360 Degrees
    Arm/Group Description 180 degrees of Selective Laser Trabeculoplasty using Neodymium:Yttrium Aluminum Garnet (YAG) laser 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. 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. 360 degrees of Selective Laser Trabeculoplasty using Neodymium:Yttrium Aluminum Garnet (YAG) laser 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. 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.
    Measure Participants 38 36
    Mean (Standard Deviation) [mm Hg]
    18.7
    (3.1)
    19.0
    (4.4)
    3. Secondary Outcome
    Title Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at Time at Which Additional Glaucoma Therapy is Required
    Description 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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title 180 Degrees 360 Degrees
    Arm/Group Description 180 degrees of Selective Laser Trabeculoplasty using Neodymium:Yttrium Aluminum Garnet (YAG) laser 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. 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. 360 degrees of Selective Laser Trabeculoplasty using Neodymium:Yttrium Aluminum Garnet (YAG) laser 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. 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.
    Measure Participants 38 36
    Mean (Standard Deviation) [mm Hg]
    24.7
    (4.0)
    23.7
    (3.3)
    4. Secondary Outcome
    Title Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at Last Follow-up
    Description Intraocular pressure (IOP) measured by tonometry in millimeters of mercury at last follow-up
    Time Frame within 1 year of study intervention

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title 180 Degrees 360 Degrees
    Arm/Group Description 180 degrees of Selective Laser Trabeculoplasty using Neodymium:Yttrium Aluminum Garnet (YAG) laser 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. 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. 360 degrees of Selective Laser Trabeculoplasty using Neodymium:Yttrium Aluminum Garnet (YAG) laser 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. 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.
    Measure Participants 38 36
    Mean (Standard Deviation) [mm Hg]
    18.2
    (2.8)
    18.3
    (4.9)
    5. Other Pre-specified Outcome
    Title Number of Participants With Intraocular Pressure (IOP) Spike Assessed by Tonometry
    Description If IOP spike occurs, it will be treated accordingly.
    Time Frame within 1 year of study intervention

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title 180 Degrees 360 Degrees
    Arm/Group Description 180 degrees of Selective Laser Trabeculoplasty using Neodymium:Yttrium Aluminum Garnet (YAG) laser 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. 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. 360 degrees of Selective Laser Trabeculoplasty using Neodymium:Yttrium Aluminum Garnet (YAG) laser 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. 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.
    Measure Participants 38 36
    Count of Participants [Participants]
    0
    0%
    0
    0%
    6. Other Pre-specified Outcome
    Title Number of Participants With Trabeculitis Assessed by Ophthalmic Exam and Gonioscopy
    Description If trabeculitis occurs, it will be treated accordingly.
    Time Frame within 1 year of study intervention

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title 180 Degrees 360 Degrees
    Arm/Group Description 180 degrees of Selective Laser Trabeculoplasty using Neodymium:Yttrium Aluminum Garnet (YAG) laser 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. 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. 360 degrees of Selective Laser Trabeculoplasty using Neodymium:Yttrium Aluminum Garnet (YAG) laser 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. 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.
    Measure Participants 38 36
    Count of Participants [Participants]
    0
    0%
    0
    0%

    Adverse Events

    Time Frame 1 year
    Adverse Event Reporting Description
    Arm/Group Title 180 Degrees 360 Degrees
    Arm/Group Description 180 degrees of Selective Laser Trabeculoplasty using Neodymium:Yttrium Aluminum Garnet (YAG) laser 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. 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. 360 degrees of Selective Laser Trabeculoplasty using Neodymium:Yttrium Aluminum Garnet (YAG) laser 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. 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.
    All Cause Mortality
    180 Degrees 360 Degrees
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/38 (0%) 0/36 (0%)
    Serious Adverse Events
    180 Degrees 360 Degrees
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/38 (0%) 0/36 (0%)
    Other (Not Including Serious) Adverse Events
    180 Degrees 360 Degrees
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/38 (0%) 1/36 (2.8%)
    Eye disorders
    Corneal Abrasian 0/38 (0%) 0 1/36 (2.8%) 1

    Limitations/Caveats

    There were some limitations to this study that include: No standardized definition of who needed laser; No standardized technique other than the amount of meshwork lasered; No standardized IOP checking device; No standardized post op drop regimen; No standardized follow up interval.

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr. Jeffrey Henderer
    Organization Temple University Hospital
    Phone 267-418-9126
    Email Jeffrey.Henderer@tuhs.temple.edu
    Responsible Party:
    Temple University
    ClinicalTrials.gov Identifier:
    NCT02628223
    Other Study ID Numbers:
    • 21921
    First Posted:
    Dec 11, 2015
    Last Update Posted:
    Nov 5, 2020
    Last Verified:
    Nov 1, 2020