Trial Outcomes & Findings for Educational Intervention to Adopt SLT as First-Line Glaucoma Treatment (NCT NCT03365778)
NCT ID: NCT03365778
Last Updated: 2020-01-30
Results Overview
Percentage of patients who elect the Selective Laser Trabeculoplasty (SLT), as treatment for lowering eye pressure, compared between a group receiving SLT Educational Intervention and a Usual Care group. Follow-up eye examinations will be screened for a 6-month period to assess number of completed SLTs.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
86 participants
Primary outcome timeframe
1 hour
Results posted on
2020-01-30
Participant Flow
Participant milestones
| Measure |
Patient Educational Intervention Group
Patients receive educational materials regarding selective laser trabeculoplasty (SLT) versus topical medication (ophthalmic eye drops) to lower eye pressure.
Educational intervention: Patients will respond to 5 questions regarding selective laser trabeculoplasty (SLT) versus topical medication to lower eye pressure. Then they will receive educational materials including 20 printed slides and view a 3 minute video on safety and efficacy of SLT. If patients agree to SLT, assistance in scheduling will be provided.
|
Usual Care Group
Patients receive standard of care.
Usual care: Patients will respond to 5 questions regarding selective laser trabeculoplasty (SLT) versus topical medication to lower eye pressure. No other guidance will be provided.
|
Ophthalmologist Educational Intervention Group
General ophthalmologists, ophthalmology residents, and glaucoma specialists in the Wills Eye Hospital physician contact database received an online survey and educational slide presentation regarding selective laser trabeculoplasty (SLT).
|
|---|---|---|---|
|
Overall Study
STARTED
|
16
|
17
|
53
|
|
Overall Study
COMPLETED
|
16
|
17
|
53
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ophthalmologists did not provide personal information such as date of birth, gender, ethnicity, race. Baseline characteristics in this group only include number of general ophthalmologists, ophthalmology residents and glaucoma specialists.
Baseline characteristics by cohort
| Measure |
Patient Educational Intervention Group
n=16 Participants
Patients receive educational materials regarding selective laser trabeculoplasty (SLT) versus topical medication (ophthalmic eye drops) to lower eye pressure.
Educational intervention: Patients will respond to 5 questions regarding selective laser trabeculoplasty (SLT) versus topical medication to lower eye pressure. Then they will receive educational materials including 20 printed slides and view a 3 minute video on safety and efficacy of SLT. If patients agree to SLT, assistance in scheduling will be provided.
|
Usual Care Group
n=17 Participants
Patients receive standard of care.
Usual care: Patients will respond to 5 questions regarding selective laser trabeculoplasty (SLT) versus topical medication to lower eye pressure. No other guidance will be provided.
|
Ophthalmologist Educational Intervention Group
n=53 Participants
General ophthalmologists, ophthalmology residents, and glaucoma specialists in the Wills Eye Hospital physician contact database received online survey and educational slide presentation regarding selective laser trabeculoplasty (SLT). No other personal information i.e. age, gender, ethnicity, race was provided by these participants.
|
Total
n=86 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=16 Participants • Ophthalmologists did not provide personal information such as date of birth, gender, ethnicity, race. Baseline characteristics in this group only include number of general ophthalmologists, ophthalmology residents and glaucoma specialists.
|
0 Participants
n=17 Participants • Ophthalmologists did not provide personal information such as date of birth, gender, ethnicity, race. Baseline characteristics in this group only include number of general ophthalmologists, ophthalmology residents and glaucoma specialists.
|
—
|
0 Participants
n=33 Participants • Ophthalmologists did not provide personal information such as date of birth, gender, ethnicity, race. Baseline characteristics in this group only include number of general ophthalmologists, ophthalmology residents and glaucoma specialists.
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=16 Participants • Ophthalmologists did not provide personal information such as date of birth, gender, ethnicity, race. Baseline characteristics in this group only include number of general ophthalmologists, ophthalmology residents and glaucoma specialists.
|
8 Participants
n=17 Participants • Ophthalmologists did not provide personal information such as date of birth, gender, ethnicity, race. Baseline characteristics in this group only include number of general ophthalmologists, ophthalmology residents and glaucoma specialists.
|
—
|
16 Participants
n=33 Participants • Ophthalmologists did not provide personal information such as date of birth, gender, ethnicity, race. Baseline characteristics in this group only include number of general ophthalmologists, ophthalmology residents and glaucoma specialists.
|
|
Age, Categorical
>=65 years
|
8 Participants
n=16 Participants • Ophthalmologists did not provide personal information such as date of birth, gender, ethnicity, race. Baseline characteristics in this group only include number of general ophthalmologists, ophthalmology residents and glaucoma specialists.
|
9 Participants
n=17 Participants • Ophthalmologists did not provide personal information such as date of birth, gender, ethnicity, race. Baseline characteristics in this group only include number of general ophthalmologists, ophthalmology residents and glaucoma specialists.
|
—
|
17 Participants
n=33 Participants • Ophthalmologists did not provide personal information such as date of birth, gender, ethnicity, race. Baseline characteristics in this group only include number of general ophthalmologists, ophthalmology residents and glaucoma specialists.
|
|
Sex: Female, Male
Female
|
8 Participants
n=16 Participants • Ophthalmologists did not provide personal information such as date of birth, gender, ethnicity, race. Baseline characteristics in this group only include number of general ophthalmologists, ophthalmology residents and glaucoma specialists.
|
7 Participants
n=17 Participants • Ophthalmologists did not provide personal information such as date of birth, gender, ethnicity, race. Baseline characteristics in this group only include number of general ophthalmologists, ophthalmology residents and glaucoma specialists.
|
—
|
15 Participants
n=33 Participants • Ophthalmologists did not provide personal information such as date of birth, gender, ethnicity, race. Baseline characteristics in this group only include number of general ophthalmologists, ophthalmology residents and glaucoma specialists.
|
|
Sex: Female, Male
Male
|
8 Participants
n=16 Participants • Ophthalmologists did not provide personal information such as date of birth, gender, ethnicity, race. Baseline characteristics in this group only include number of general ophthalmologists, ophthalmology residents and glaucoma specialists.
|
10 Participants
n=17 Participants • Ophthalmologists did not provide personal information such as date of birth, gender, ethnicity, race. Baseline characteristics in this group only include number of general ophthalmologists, ophthalmology residents and glaucoma specialists.
|
—
|
18 Participants
n=33 Participants • Ophthalmologists did not provide personal information such as date of birth, gender, ethnicity, race. Baseline characteristics in this group only include number of general ophthalmologists, ophthalmology residents and glaucoma specialists.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=16 Participants
|
1 Participants
n=17 Participants
|
0 Participants
n=53 Participants
|
2 Participants
n=86 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=16 Participants
|
14 Participants
n=17 Participants
|
0 Participants
n=53 Participants
|
23 Participants
n=86 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=16 Participants
|
2 Participants
n=17 Participants
|
53 Participants
n=53 Participants
|
61 Participants
n=86 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=16 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=86 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=16 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=53 Participants
|
1 Participants
n=86 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=16 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=86 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=16 Participants
|
13 Participants
n=17 Participants
|
0 Participants
n=53 Participants
|
18 Participants
n=86 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=16 Participants
|
2 Participants
n=17 Participants
|
0 Participants
n=53 Participants
|
7 Participants
n=86 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=16 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=86 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=16 Participants
|
2 Participants
n=17 Participants
|
53 Participants
n=53 Participants
|
60 Participants
n=86 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=16 Participants
|
17 participants
n=17 Participants
|
53 participants
n=53 Participants
|
86 participants
n=86 Participants
|
|
Type of Ophthalmologist
General ophthalmologists
|
0 Participants
Patient Educational Intervention and Usual Care Groups are not compared in Type of Ophthalmologist baseline data.
|
0 Participants
Patient Educational Intervention and Usual Care Groups are not compared in Type of Ophthalmologist baseline data.
|
26 Participants
n=53 Participants • Patient Educational Intervention and Usual Care Groups are not compared in Type of Ophthalmologist baseline data.
|
26 Participants
n=53 Participants • Patient Educational Intervention and Usual Care Groups are not compared in Type of Ophthalmologist baseline data.
|
|
Type of Ophthalmologist
Ophthalmology Residents
|
0 Participants
Patient Educational Intervention and Usual Care Groups are not compared in Type of Ophthalmologist baseline data.
|
0 Participants
Patient Educational Intervention and Usual Care Groups are not compared in Type of Ophthalmologist baseline data.
|
5 Participants
n=53 Participants • Patient Educational Intervention and Usual Care Groups are not compared in Type of Ophthalmologist baseline data.
|
5 Participants
n=53 Participants • Patient Educational Intervention and Usual Care Groups are not compared in Type of Ophthalmologist baseline data.
|
|
Type of Ophthalmologist
Glaucoma Specialists
|
0 Participants
Patient Educational Intervention and Usual Care Groups are not compared in Type of Ophthalmologist baseline data.
|
0 Participants
Patient Educational Intervention and Usual Care Groups are not compared in Type of Ophthalmologist baseline data.
|
22 Participants
n=53 Participants • Patient Educational Intervention and Usual Care Groups are not compared in Type of Ophthalmologist baseline data.
|
22 Participants
n=53 Participants • Patient Educational Intervention and Usual Care Groups are not compared in Type of Ophthalmologist baseline data.
|
PRIMARY outcome
Timeframe: 1 hourPercentage of patients who elect the Selective Laser Trabeculoplasty (SLT), as treatment for lowering eye pressure, compared between a group receiving SLT Educational Intervention and a Usual Care group. Follow-up eye examinations will be screened for a 6-month period to assess number of completed SLTs.
Outcome measures
| Measure |
Educational Intervention Group
n=16 Participants
Patients receive educational materials regarding selective laser trabeculoplasty (SLT) versus topical medication (ophthalmic eye drops) to lower eye pressure.
Educational intervention: Patients will respond to 5 questions regarding selective laser trabeculoplasty (SLT) versus topical medication to lower eye pressure. Then they will receive educational materials including 20 printed slides and view a 3 minute video on safety and efficacy of SLT. If patients agree to SLT, assistance in scheduling will be provided.
|
Usual Care Group
n=17 Participants
Patients receive standard of care.
Usual care: Patients will respond to 5 questions regarding selective laser trabeculoplasty (SLT) versus topical medication to lower eye pressure. No other guidance will be provided.
|
|---|---|---|
|
Completion of Selective Laser Trabeculoplasty (SLT)
|
10 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: 1 hourPopulation: Usual Care group not included since they did not receive education intervention.
Attitudes were assessed in the Patient Educational Intervention group before and immediately following intervention to determine how receptive they were regarding Selective Laser Trabeculoplasty (SLT) as a therapy to lowering eye pressure as compared to the more common therapy of daily eye drops.
Outcome measures
| Measure |
Educational Intervention Group
n=16 Participants
Patients receive educational materials regarding selective laser trabeculoplasty (SLT) versus topical medication (ophthalmic eye drops) to lower eye pressure.
Educational intervention: Patients will respond to 5 questions regarding selective laser trabeculoplasty (SLT) versus topical medication to lower eye pressure. Then they will receive educational materials including 20 printed slides and view a 3 minute video on safety and efficacy of SLT. If patients agree to SLT, assistance in scheduling will be provided.
|
Usual Care Group
Patients receive standard of care.
Usual care: Patients will respond to 5 questions regarding selective laser trabeculoplasty (SLT) versus topical medication to lower eye pressure. No other guidance will be provided.
|
|---|---|---|
|
Measure Educational Effects of Selective Laser Trabeculoplasty (SLT)
Pre-Intervention Yes
|
0 Participants
|
0 Participants
|
|
Measure Educational Effects of Selective Laser Trabeculoplasty (SLT)
Post-Intervention Yes
|
12 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 minutesTo evaluate barriers for widespread adoption of selective laser trabeculoplasty (SLT) as first line treatment of high eye pressure, we assessed the beliefs and attitudes of ophthalmologists regarding SLT. An educational slide presentation and survey targeted physicians to increase awareness and consideration of SLT earlier in the glaucoma treatment paradigm. Number of respondents who currently offer laser treatment for newly diagnosed glaucoma patients.
Outcome measures
| Measure |
Educational Intervention Group
n=53 Participants
Patients receive educational materials regarding selective laser trabeculoplasty (SLT) versus topical medication (ophthalmic eye drops) to lower eye pressure.
Educational intervention: Patients will respond to 5 questions regarding selective laser trabeculoplasty (SLT) versus topical medication to lower eye pressure. Then they will receive educational materials including 20 printed slides and view a 3 minute video on safety and efficacy of SLT. If patients agree to SLT, assistance in scheduling will be provided.
|
Usual Care Group
Patients receive standard of care.
Usual care: Patients will respond to 5 questions regarding selective laser trabeculoplasty (SLT) versus topical medication to lower eye pressure. No other guidance will be provided.
|
|---|---|---|
|
Measure Educational Effects of Selective Laser Trabeculoplasty (SLT) Among Ophthalmologists
|
45 Participants
|
—
|
Adverse Events
Patient Educational Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ophthalmologist Educational Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place