Glaucoma, Glaucoma, Open Angle, Pseudo-exfoliative, Ocular Hypertension, Open Angle Glaucoma, Pigment Dispersion Syndrome
Conditions
Keywords
glaucoma, Elevated IOP, Selective Laser Trabeculoplasty, SLT, open angle glaucoma, ocular hypertension, Glaucoma, Open Angle, Pseudo-exfoliative, pigment dispersion syndrome, Pseudoexfoliation, IOP ≥ 21 mmHg
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.
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.
Interventions
PROCEDURESelective 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.
DEVICENeodymium: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.
Sponsors
Temple University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 38 |
| 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. | 38 |
| Total | 76 |
Baseline characteristics
| Characteristic | 180 Degrees | 360 Degrees | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 29 Participants | 33 Participants | 62 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 5 Participants | 14 Participants |
| Age, Continuous | 71.4 years STANDARD_DEVIATION 8.6 | 71.9 years STANDARD_DEVIATION 6.7 | 71.6 years STANDARD_DEVIATION 7.7 |
| Diabetes | 9 Participants | 14 Participants | 23 Participants |
| Glaucoma (mild, moderate, severe, indeterminant) Indeterminant | 7 Participants | 0 Participants | 7 Participants |
| Glaucoma (mild, moderate, severe, indeterminant) Mild | 13 Participants | 12 Participants | 25 Participants |
| Glaucoma (mild, moderate, severe, indeterminant) Moderate | 4 Participants | 8 Participants | 12 Participants |
| Glaucoma (mild, moderate, severe, indeterminant) No Glaucoma | 13 Participants | 16 Participants | 29 Participants |
| Glaucoma (mild, moderate, severe, indeterminant) Severe | 1 Participants | 2 Participants | 3 Participants |
| Hypertension | 25 Participants | 29 Participants | 54 Participants |
| Ocular Hypertension | 8 Participants | 12 Participants | 20 Participants |
| Pigment Dispersion Syndrome | 0 Participants | 0 Participants | 0 Participants |
| Pseudoexfoliation | 6 Participants | 1 Participants | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 8 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 32 Participants | 28 Participants | 60 Participants |
| Sex: Female, Male Female | 19 Participants | 20 Participants | 39 Participants |
| Sex: Female, Male Male | 19 Participants | 18 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 36 |
| other Total, other adverse events | 0 / 38 | 1 / 36 |
| serious Total, serious adverse events | 0 / 38 | 0 / 36 |
Outcome results
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
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 180 Degrees | Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at Three Months of Follow-up | 20.7 mm Hg | Standard Deviation 5.4 |
| 360 Degrees | Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at Three Months of Follow-up | 19.1 mm Hg | Standard Deviation 4.1 |
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
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 180 Degrees | Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at 1 Year of Follow-up | 18.7 mm Hg | Standard Deviation 3.1 |
| 360 Degrees | Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at 1 Year of Follow-up | 19.0 mm Hg | Standard Deviation 4.4 |
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
Time frame: within 1 year of study intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 180 Degrees | Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at Last Follow-up | 18.2 mm Hg | Standard Deviation 2.8 |
| 360 Degrees | Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at Last Follow-up | 18.3 mm Hg | Standard Deviation 4.9 |
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
Time frame: within 1 year of study intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 180 Degrees | Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at Time at Which Additional Glaucoma Therapy is Required | 24.7 mm Hg | Standard Deviation 4 |
| 360 Degrees | Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at Time at Which Additional Glaucoma Therapy is Required | 23.7 mm Hg | Standard Deviation 3.3 |
Other Pre-specified
Number of Participants With Intraocular Pressure (IOP) Spike Assessed by Tonometry
If IOP spike occurs, it will be treated accordingly.
Time frame: within 1 year of study intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 180 Degrees | Number of Participants With Intraocular Pressure (IOP) Spike Assessed by Tonometry | 0 Participants |
| 360 Degrees | Number of Participants With Intraocular Pressure (IOP) Spike Assessed by Tonometry | 0 Participants |
Other Pre-specified
Number of Participants With Trabeculitis Assessed by Ophthalmic Exam and Gonioscopy
If trabeculitis occurs, it will be treated accordingly.
Time frame: within 1 year of study intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 180 Degrees | Number of Participants With Trabeculitis Assessed by Ophthalmic Exam and Gonioscopy | 0 Participants |
| 360 Degrees | Number of Participants With Trabeculitis Assessed by Ophthalmic Exam and Gonioscopy | 0 Participants |