180 Degree vs. 360 Degree Selective Laser Trabeculoplasty as Initial Therapy for Glaucoma
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 |
---|---|---|
|
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
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:
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:
|
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:
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:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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 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 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
- 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.
Eligibility Criteria
Criteria
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.- 21921
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
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)
|
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)
|
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)
|
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)
|
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%
|
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
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 |
Jeffrey.Henderer@tuhs.temple.edu |
- 21921