Primary Open-angle Glaucoma
Conditions
Keywords
educational intervention, SLT, selective laser trabeculoplasty, POAG, eye drops, Primary Open Angle Glaucoma
Brief summary
The purpose of this study is to develop an educational program that will help improve the patients' understanding of what laser treatment is, how it might be beneficial to them, and why it should be the first eye pressure lowering glaucoma treatment to consider before the use of glaucoma eye drops.
Detailed description
Glaucoma is a disease characterized by optic nerve damage, visual field defects, elevated intraocular pressure (IOP) and progressive vision loss. More than 3 million Americans have glaucoma and more than 150,000 are blind as a result. Regular use of glaucoma medications can usually lower intraocular pressure (IOP), prevent disease progression, preserve vision and prevent blindness. However, many people with glaucoma do not always use their medication as directed, with about one-third to one-half of patients with glaucoma not taking their drops as often as necessary, or have difficulty putting in the drops. There are also numerous local side effects from using glaucoma eye drops including red eyes, blurry vision and dry eye symptoms. Systemic side effects from eye drops range from triggering asthma, to lethargy and depression. Selective laser trabeculoplasty (SLT) has been used safely and effectively for the treatment of elevated IOP in patients with open angle glaucoma for more than 20 years. SLT may result in mild and temporary IOP elevation, but this is a small risk and rarely significant. Other side effects include blurred vison and inflammation of the cornea (front, clear part of the eye), but they are extremely rare. The purpose of this study is to develop an educational program that will help improve the patients' understanding of what laser treatment is, how it might be beneficial to them, and why it should be considered as first glaucoma treatment before the use of glaucoma eye drops.
Interventions
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.
OTHERUsual 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.
OTHEROphthalmologist Educational Intervention
Responses to online survey regarding beliefs and attitudes towards selective laser trabeculoplasty (SLT) before and after educational slide presentation were recorded and compared between physician specialty groups.
Sponsors
Wills Eye
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Selective Laser Trabeculoplasty (SLT) Educational Intervention group (n=20) or Usual Care group (n=20). Knowledge, beliefs, barriers, and attitudes about SLT vs. medication as first line treatment of glaucoma will be assessed in both groups. To evaluate barriers for widespread adoption of this procedure, we assessed beliefs and attitudes of ophthalmologists regarding SLT. We developed an educational slide presentation targeted at physicians to increase consideration of SLT earlier in glaucoma treatment paradigm.
Eligibility
Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* patients between 40 and 90 years of age * high-risk ocular hypertension, primary open-angle glaucoma, or pseudo-exfoliation glaucoma * currently treated with at least one glaucoma eye drop with stable intraocular pressure
Exclusion criteria
* previous laser trabeculoplasty * previous glaucoma surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completion of Selective Laser Trabeculoplasty (SLT) | 1 hour | 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. |
| Measure Educational Effects of Selective Laser Trabeculoplasty (SLT) | 1 hour | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measure Educational Effects of Selective Laser Trabeculoplasty (SLT) Among Ophthalmologists | 30 minutes | To 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 16 |
| 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. | 17 |
| Ophthalmologist Educational Intervention Group 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. | 53 |
| Total | 86 |
Baseline characteristics
| Characteristic | Total | Patient Educational Intervention Group | Usual Care Group | Ophthalmologist Educational Intervention Group |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | — |
| Age, Categorical >=65 years | 17 Participants | 8 Participants | 9 Participants | — |
| Age, Categorical Between 18 and 65 years | 16 Participants | 8 Participants | 8 Participants | — |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants | 9 Participants | 14 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 61 Participants | 6 Participants | 2 Participants | 53 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants | 5 Participants | 13 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 60 Participants | 5 Participants | 2 Participants | 53 Participants |
| Race (NIH/OMB) White | 7 Participants | 5 Participants | 2 Participants | 0 Participants |
| Region of Enrollment United States | 86 participants | 16 participants | 17 participants | 53 participants |
| Sex: Female, Male Female | 15 Participants | 8 Participants | 7 Participants | — |
| Sex: Female, Male Male | 18 Participants | 8 Participants | 10 Participants | — |
| Type of Ophthalmologist General ophthalmologists | 26 Participants | 0 Participants | 0 Participants | 26 Participants |
| Type of Ophthalmologist Glaucoma Specialists | 22 Participants | 0 Participants | 0 Participants | 22 Participants |
| Type of Ophthalmologist Ophthalmology Residents | 5 Participants | 0 Participants | 0 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 17 | 0 / 53 |
| other Total, other adverse events | 0 / 16 | 0 / 17 | 0 / 53 |
| serious Total, serious adverse events | 0 / 16 | 0 / 17 | 0 / 53 |
Outcome results
Primary
Completion of Selective Laser Trabeculoplasty (SLT)
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.
Time frame: 1 hour
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Educational Intervention Group | Completion of Selective Laser Trabeculoplasty (SLT) | 10 Participants |
| Usual Care Group | Completion of Selective Laser Trabeculoplasty (SLT) | 6 Participants |
Primary
Measure Educational Effects of Selective Laser Trabeculoplasty (SLT)
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.
Time frame: 1 hour
Population: Usual Care group not included since they did not receive education intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Educational Intervention Group | Measure Educational Effects of Selective Laser Trabeculoplasty (SLT) | Post-Intervention Yes | 12 Participants |
| Educational Intervention Group | Measure Educational Effects of Selective Laser Trabeculoplasty (SLT) | Pre-Intervention Yes | 0 Participants |
| Usual Care Group | Measure Educational Effects of Selective Laser Trabeculoplasty (SLT) | Pre-Intervention Yes | 0 Participants |
| Usual Care Group | Measure Educational Effects of Selective Laser Trabeculoplasty (SLT) | Post-Intervention Yes | 0 Participants |
Secondary
Measure Educational Effects of Selective Laser Trabeculoplasty (SLT) Among Ophthalmologists
To 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.
Time frame: 30 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Educational Intervention Group | Measure Educational Effects of Selective Laser Trabeculoplasty (SLT) Among Ophthalmologists | 45 Participants |