Glaucoma
Conditions
Keywords
Glaucoma, Trabeculoplasty, Selective laser trabeculoplasty, Intraocular pressure
Brief summary
The purpose of this study is to determine whether the choice of post-operative eye drop administered after selective laser trabeculoplasty (SLT) for glaucoma affects the efficacy in lowering intraocular pressure (IOP).
Detailed description
SLT is used to lower intraocular pressure in glaucoma, but it is not know whether the choice of eyedrops administered in the post-operative period affects SLT efficacy. Practitioners commonly use steroid drops, non-steroidal anti-inflammatory drops, or no drops at all. This is a randomized, single-center, prospective, masked clinical trial to determine whether the choice of eyedrop affects efficacy of SLT in glaucoma patients.
Interventions
DRUGPrednisolone 1%
Prednisolone 1% to lasered eye 4 times/day for 4.5 days
DRUGKetorolac
Ketorolac 0.5% to lasered eye 4 times/day for 4.5 days
DRUGArtificial Tears
Artificial saline tears to lasered eye 4 times/day for 4.5 days
Sponsors
Bascom Palmer Eye Institute
University of Pittsburgh Medical Center
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* clinical diagnosis of glaucoma * clinician has determined that SLT laser is indicated * IOP currently \>18 and was ever \>21 in the past (e.g. prior to treatment)
Exclusion criteria
* prior history of uveitis * prior glaucoma surgery including glaucoma laser surgery * pregnant or 3 months post-partum
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraocular Pressure (IOP) Change | Baseline to Week 12 | IOP will be measured before and at 6 and 12 weeks after intervention using Goldman tonometry. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraocular Inflammation | Up to week 12 | The count of patients with inflammation defined as anterior chamber cells was measured in each study arm. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Artificial Tears Artificial Tears: Artificial saline tears to lasered eye 4 times/day for 4.5 days | 31 |
| Non-steroidal Anti-inflammatory Diclofenac 0.1%: Diclofenac sodium 0.1% to lasered eye 4 times/day for 4.5 days | 29 |
| Steroid Prednisolone 1%: Prednisolone 1% to lasered eye 4 times/day for 4.5 days | 37 |
| Total | 97 |
Baseline characteristics
| Characteristic | Artificial Tears | Non-steroidal Anti-inflammatory | Steroid | Total |
|---|---|---|---|---|
| Age, Continuous | 66 years STANDARD_DEVIATION 15 | 60 years STANDARD_DEVIATION 11 | 67 years STANDARD_DEVIATION 14 | 65 years STANDARD_DEVIATION 14 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 5 Participants | 11 Participants | 26 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 23 Participants | 24 Participants | 67 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 7 Participants | 8 Participants | 21 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 | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 25 Participants | 21 Participants | 29 Participants | 75 Participants |
| Sex: Female, Male Female | 19 Participants | 14 Participants | 23 Participants | 56 Participants |
| Sex: Female, Male Male | 12 Participants | 15 Participants | 14 Participants | 41 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 / 31 | 0 / 29 | 0 / 37 |
| serious Total, serious adverse events | 0 / 31 | 0 / 29 | 0 / 37 |
Outcome results
Primary
Intraocular Pressure (IOP) Change
IOP will be measured before and at 6 and 12 weeks after intervention using Goldman tonometry.
Time frame: Baseline to Week 12
Population: Patient data was incomplete due to inadequate measurement or follow up as follows: Artificial tears (31 enrolled, 27 available at 6 weeks, 25 at 12 weeks); Non-steroidal anti-inflammatory (28 enrolled, 27 available at 6 and 12 weeks); Steroid (37 enrolled, 33 available at 6 weeks, 29 at 12 weeks).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Artificial Tears | Intraocular Pressure (IOP) Change | -3.0 mmHg | Standard Deviation 4.3 |
| Non-steroidal Anti-inflammatory | Intraocular Pressure (IOP) Change | -6.2 mmHg | Standard Deviation 3.1 |
| Steroid | Intraocular Pressure (IOP) Change | -5.2 mmHg | Standard Deviation 2.7 |
Secondary
Intraocular Inflammation
The count of patients with inflammation defined as anterior chamber cells was measured in each study arm.
Time frame: Up to week 12
Population: Patient data was incomplete due to inadequate measurement or follow up as follows: Artificial tears (31 enrolled, 31 available for data acquisition); Non-steroidal anti-inflammatory (29 enrolled, 26 available for data acquisition); Steroid (37 enrolled, 35 available for data acquisition).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Artificial Tears | Intraocular Inflammation | 0 Participants |
| Non-steroidal Anti-inflammatory | Intraocular Inflammation | 0 Participants |
| Steroid | Intraocular Inflammation | 0 Participants |