Open Angle Glaucoma
Conditions
Keywords
glaucoma, selective laser trabeculoplasty, anterior chamber flare
Brief summary
The Investigators will compare, in a randomized, prospective, masked and controlled fashion the effect of a non-steroidal anti-inflammatory agent (Acular LS), a corticosteroid (Pred Forte) and a placebo (Refresh Tears) on patient discomfort, degree of intraocular pressure (IOP) lowering and degree of ocular inflammation following selective laser trabeculoplasty treatment for open angle glaucoma.
Detailed description
Currently, many ophthalmologists use anti-inflammatory agents like corticosteroids and nonsteroidal anti-inflammatory agents (NSAIDs) as a preventative measure to control the post-selective laser trabeculoplasty (SLT) anterior chamber inflammation. Both classes of compounds reduce inflammation through the inhibition of the cyclooxygenase pathway, whereas the corticosteroid class also inhibits the lipoxygenase pathway of the arachidonic acid cascade. Although effective, topical corticosteroids are associated with increase in intraocular pressure (IOP), posterior subcapsular cataract formation, and reduced response to infection. These adverse side effects have not been reported to occur with topical NSAIDs, which are effective in controlling the pain after SLT along with the prevention and suppression of the ocular inflammation. There are ophthalmologists who forgo using the anti-inflammatory agents post SLT and prescribe Refresh Tears to their patients to comfort the treated eye. The significance of the study lies in assessing the efficacy of Acular LS, compared to Pred Forte and to Refresh Tears in reducing discomfort, inflammation and maximizing IOP lowering following SLT procedure for open angle glaucoma with the hope of resolving the dispute over the effective post-operative care in SLT patients.
Interventions
DRUGAcular LS
Details covered in arm description
DRUGPred Forte
Details covered in arm description
OTHERRefresh Tears
Placebo
Sponsors
University of Colorado, Denver
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
* Diagnosed with open angle glaucoma patients at the Rocky Mountain Lions Eye Institute Glaucoma Clinic. * Able to provide written informed consent to participate. * Must be the age of 18 years of age or older. * Patients in which further intraocular pressure lowering by selective laser trabeculoplasty is necessary in the opinion of the treating physician.
Exclusion criteria
* Patients with eye surgery in the prior six months. * Patients with prior or current use of topical or systemic corticosteroids or NSAIDs. * Patients with pre-existing anterior chamber inflammation. * Patients with known sensitivity to any of the study medications. * Due to the age range and the disease entity, special patient populations such as children or pregnant women will not be enrolled in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Interocular Pressure | 8 weeks | IOP, measured by Goldmann applanation tonometry |
Countries
United States
Participant flow
Recruitment details
Prospective study participants will be identified by a routine clinic visit at Rocky Mountain Lions Eye Institute, University of Colorado, and need to undergo selective laser trabeculoplasty treatment for their glaucoma. A study investigator will make the initial patient contact for recruitment.
Pre-assignment details
The patients enrolled in this study will follow standard of care practice in regards to selective laser trabeculoplasty with the exception that the patients will be randomized 1:1:1 (Acular LS: Pred Forte: Refresh Tears) to the inflammation treatment given after the procedure.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Group Refresh Tears - 1 drop in treated eye, 4 times a day, for 4 days | 14 |
| Acular Group Used acular LS | 10 |
| Predforte Group Used predforte eye drops | 7 |
| Total | 31 |
Baseline characteristics
| Characteristic | Placebo Group | Acular Group | Predforte Group | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 11 Participants | 6 Participants | 6 Participants | 23 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 4 Participants | 1 Participants | 8 Participants |
| Age, Continuous | 68 years | 69.5 years | 73 years | 69 years |
| Sex: Female, Male Female | 13 Participants | 6 Participants | 3 Participants | 22 Participants |
| Sex: Female, Male Male | 1 Participants | 4 Participants | 4 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 7 | 0 / 14 |
| serious Total, serious adverse events | 0 / 10 | 0 / 7 | 0 / 14 |
Outcome results
Primary
Interocular Pressure
IOP, measured by Goldmann applanation tonometry
Time frame: 8 weeks
Population: Reported for subjects for whom all IOP values were available for all of the visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acular LS | Interocular Pressure | week 8 | 14.0 mmHg | Standard Deviation 2.3 |
| Acular LS | Interocular Pressure | Week 1 | 15.2 mmHg | Standard Deviation 3.3 |
| Acular LS | Interocular Pressure | Day 1 | 11.6 mmHg | Standard Deviation 2.2 |
| Acular LS | Interocular Pressure | Baseline | 16.1 mmHg | Standard Deviation 3.1 |
| Acular LS | Interocular Pressure | Week 4 | 14.3 mmHg | Standard Deviation 2.6 |
| Pred Forte | Interocular Pressure | Baseline | 17.0 mmHg | Standard Deviation 3.3 |
| Pred Forte | Interocular Pressure | week 8 | 15.0 mmHg | Standard Deviation 1.6 |
| Pred Forte | Interocular Pressure | Week 4 | 14.0 mmHg | Standard Deviation 2.4 |
| Pred Forte | Interocular Pressure | Week 1 | 15.7 mmHg | Standard Deviation 2.8 |
| Pred Forte | Interocular Pressure | Day 1 | 12.4 mmHg | Standard Deviation 2.5 |
| Refresh Tears | Interocular Pressure | week 8 | 15.8 mmHg | Standard Deviation 3.1 |
| Refresh Tears | Interocular Pressure | Week 1 | 15.6 mmHg | Standard Deviation 3.7 |
| Refresh Tears | Interocular Pressure | Baseline | 17.8 mmHg | Standard Deviation 4.5 |
| Refresh Tears | Interocular Pressure | Week 4 | 14.6 mmHg | Standard Deviation 3.5 |
| Refresh Tears | Interocular Pressure | Day 1 | 13.4 mmHg | Standard Deviation 3.3 |