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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 180 degrees | Active Comparator | 180 degrees of Selective Laser Trabeculoplasty using Neodymium:Yttrium Aluminum Garnet (YAG) laser |
|
| 360 degrees | Active Comparator | 360 degrees of Selective Laser Trabeculoplasty using Neodymium:Yttrium Aluminum Garnet (YAG) laser |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at Three Months of Follow-up | Intraocular pressure (IOP) measured by tonometry in millimeters of mercury at three months of follow-up | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at 1 Year of Follow-up | 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 Time at Which Additional Glaucoma Therapy is Required |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Intraocular Pressure (IOP) Spike Assessed by Tonometry | If IOP spike occurs, it will be treated accordingly. | within 1 year of study intervention |
| Number of Participants With Trabeculitis Assessed by Ophthalmic Exam and Gonioscopy |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey D. Henderer, MD | Temple University | Principal Investigator |
| Sophia Siu, MD | Temple University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brandywine Eye Center | Wilmington | Delaware | 19810 | United States | ||
| Levin Luminais Chronister Eye Associates |
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| ID | Title | Description |
|---|---|---|
| FG000 | 180 Degrees | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 13, 2016 |
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| 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. |
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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 Last Follow-up | Intraocular pressure (IOP) measured by tonometry in millimeters of mercury at last follow-up | within 1 year of study intervention |
If trabeculitis occurs, it will be treated accordingly.
| within 1 year of study intervention |
| Thorndale |
| Pennsylvania |
| 19372 |
| United States |
| FG001 | 360 Degrees | 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. |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 180 Degrees | 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. |
| BG001 | 360 Degrees | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Hypertension | Count of Participants | Participants |
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| Diabetes | Count of Participants | Participants |
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| Glaucoma (mild, moderate, severe, indeterminant) | Count of Participants | Participants |
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| Ocular Hypertension | Count of Participants | Participants |
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| Pseudoexfoliation | Count of Participants | Participants |
| ||||||||||||||||||
| Pigment Dispersion Syndrome | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at Three Months of Follow-up | Intraocular pressure (IOP) measured by tonometry in millimeters of mercury at three months of follow-up | Posted | Mean | Standard Deviation | mm Hg | 3 months |
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| |||||||||||||||||||||||||||||
| Secondary | Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at 1 Year of Follow-up | Intraocular pressure (IOP) measured by tonometry in millimeters of mercury at 1 year of follow-up | Posted | Mean | Standard Deviation | mm Hg | 1 year |
| |||||||||||||||||||||||||||||||
| Secondary | Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at Time at Which Additional Glaucoma Therapy is Required | Intraocular pressure (IOP) measured by tonometry in millimeters of mercury at time at which additional glaucoma therapy is required | Posted | Mean | Standard Deviation | mm Hg | within 1 year of study intervention |
| |||||||||||||||||||||||||||||||
| Secondary | Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at Last Follow-up | Intraocular pressure (IOP) measured by tonometry in millimeters of mercury at last follow-up | Posted | Mean | Standard Deviation | mm Hg | within 1 year of study intervention |
| |||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Intraocular Pressure (IOP) Spike Assessed by Tonometry | If IOP spike occurs, it will be treated accordingly. | Posted | Count of Participants | Participants | within 1 year of study intervention |
| ||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Trabeculitis Assessed by Ophthalmic Exam and Gonioscopy | If trabeculitis occurs, it will be treated accordingly. | Posted | Count of Participants | Participants | within 1 year of study intervention |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 180 Degrees | 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. | 0 | 38 | 0 | 38 | 0 | 38 |
| EG001 | 360 Degrees | 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. | 0 | 36 | 0 | 36 | 1 | 36 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Corneal Abrasian | Eye disorders | Systematic Assessment |
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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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jeffrey Henderer | Temple University Hospital | 267-418-9126 | Jeffrey.Henderer@tuhs.temple.edu |
| Nov 3, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| D005901 | Glaucoma |
| C563184 | Glaucoma-Related Pigment Dispersion Syndrome |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D007834 | Lasers |
| ID | Term |
|---|---|
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Moderate |
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| Severe |
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| Indeterminant |
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| No Glaucoma |
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