Trial Outcomes & Findings for 180 Degree vs. 360 Degree Selective Laser Trabeculoplasty as Initial Therapy for Glaucoma (NCT NCT02628223)
NCT ID: NCT02628223
Last Updated: 2020-11-05
Results Overview
Intraocular pressure (IOP) measured by tonometry in millimeters of mercury at three months of follow-up
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
76 participants
Primary outcome timeframe
3 months
Results posted on
2020-11-05
Participant Flow
Participant milestones
| Measure |
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.
|
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.
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|---|---|---|
|
Overall Study
STARTED
|
38
|
38
|
|
Overall Study
COMPLETED
|
38
|
36
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
180 Degree vs. 360 Degree Selective Laser Trabeculoplasty as Initial Therapy for Glaucoma
Baseline characteristics by cohort
| Measure |
180 Degrees
n=38 Participants
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
n=38 Participants
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.
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Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
29 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
|
Age, Continuous
|
71.4 years
STANDARD_DEVIATION 8.6 • n=99 Participants
|
71.9 years
STANDARD_DEVIATION 6.7 • n=107 Participants
|
71.6 years
STANDARD_DEVIATION 7.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Hypertension
|
25 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Diabetes
|
9 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Glaucoma (mild, moderate, severe, indeterminant)
Mild
|
13 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Glaucoma (mild, moderate, severe, indeterminant)
Moderate
|
4 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Glaucoma (mild, moderate, severe, indeterminant)
Severe
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Glaucoma (mild, moderate, severe, indeterminant)
Indeterminant
|
7 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Glaucoma (mild, moderate, severe, indeterminant)
No Glaucoma
|
13 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Ocular Hypertension
|
8 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Pseudoexfoliation
|
6 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Pigment Dispersion Syndrome
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 3 monthsIntraocular pressure (IOP) measured by tonometry in millimeters of mercury at three months of follow-up
Outcome measures
| Measure |
180 Degrees
n=38 Participants
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
n=36 Participants
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.
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|---|---|---|
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Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at Three Months of Follow-up
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20.7 mm Hg
Standard Deviation 5.4
|
19.1 mm Hg
Standard Deviation 4.1
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SECONDARY outcome
Timeframe: 1 yearIntraocular pressure (IOP) measured by tonometry in millimeters of mercury at 1 year of follow-up
Outcome measures
| Measure |
180 Degrees
n=38 Participants
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
n=36 Participants
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.
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|---|---|---|
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Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at 1 Year of Follow-up
|
18.7 mm Hg
Standard Deviation 3.1
|
19.0 mm Hg
Standard Deviation 4.4
|
SECONDARY outcome
Timeframe: within 1 year of study interventionIntraocular pressure (IOP) measured by tonometry in millimeters of mercury at time at which additional glaucoma therapy is required
Outcome measures
| Measure |
180 Degrees
n=38 Participants
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
n=36 Participants
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.
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|---|---|---|
|
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 4.0
|
23.7 mm Hg
Standard Deviation 3.3
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SECONDARY outcome
Timeframe: within 1 year of study interventionIntraocular pressure (IOP) measured by tonometry in millimeters of mercury at last follow-up
Outcome measures
| Measure |
180 Degrees
n=38 Participants
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
n=36 Participants
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.
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|---|---|---|
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Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at Last Follow-up
|
18.2 mm Hg
Standard Deviation 2.8
|
18.3 mm Hg
Standard Deviation 4.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: within 1 year of study interventionIf IOP spike occurs, it will be treated accordingly.
Outcome measures
| Measure |
180 Degrees
n=38 Participants
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
n=36 Participants
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.
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|---|---|---|
|
Number of Participants With Intraocular Pressure (IOP) Spike Assessed by Tonometry
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: within 1 year of study interventionIf trabeculitis occurs, it will be treated accordingly.
Outcome measures
| Measure |
180 Degrees
n=38 Participants
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
n=36 Participants
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.
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|---|---|---|
|
Number of Participants With Trabeculitis Assessed by Ophthalmic Exam and Gonioscopy
|
0 Participants
|
0 Participants
|
Adverse Events
180 Degrees
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
360 Degrees
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
180 Degrees
n=38 participants at risk
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
n=36 participants at risk
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.
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|---|---|---|
|
Eye disorders
Corneal Abrasian
|
0.00%
0/38 • 1 year
|
2.8%
1/36 • Number of events 1 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place