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| Name | Class |
|---|---|
| Bascom Palmer Eye Institute | OTHER |
| University of Pittsburgh Medical Center | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Artificial Tears | Experimental | Topical artificial tears dosed 4 times per day for 4 days in treated eye after laser trabeculoplasty. |
|
| Non-steroidal anti-inflammatory | Experimental | Topical ketorolac 0.5% dosed 4 times per day for 4 days in treated eye after laser trabeculoplasty. |
|
| Steroid | Experimental | Topical prednisolone 1% dosed 4 times per day for 4 days in treated eye after laser trabeculoplasty. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisolone 1% | Drug | Prednisolone 1% to lasered eye 4 times/day for 4.5 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular Pressure (IOP) Change | IOP will be measured before and at 6 and 12 weeks after intervention using Goldman tonometry. | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular Inflammation | The count of patients with inflammation defined as anterior chamber cells was measured in each study arm. | Up to week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey L Goldberg, MD, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bascom Palmer Eye Institute | Miami | Florida | 33136 | United States | ||
| University of Pittsburgh Medical Center |
IPD is anticipated to be shared upon publication of results.
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| ID | Title | Description |
|---|---|---|
| FG000 | Artificial Tears | Artificial Tears: Artificial saline tears to lasered eye 4 times/day for 4.5 days |
| FG001 | Non-steroidal Anti-inflammatory | Diclofenac 0.1%: Diclofenac sodium 0.1% to lasered eye 4 times/day for 4.5 days |
| FG002 | Steroid | Prednisolone 1%: Prednisolone 1% to lasered eye 4 times/day for 4.5 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Artificial Tears | Artificial Tears: Artificial saline tears to lasered eye 4 times/day for 4.5 days |
| BG001 | Non-steroidal Anti-inflammatory | Diclofenac 0.1%: Diclofenac sodium 0.1% to lasered eye 4 times/day for 4.5 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Intraocular Pressure (IOP) Change | IOP will be measured before and at 6 and 12 weeks after intervention using Goldman tonometry. | 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). | Posted | Mean | Standard Deviation | mmHg | Baseline to Week 12 |
|
Up to 12 weeks
Adverse events and serious adverse events were pre-defined and evaluated by examining physician at every study visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Artificial Tears | Artificial Tears: Artificial saline tears to lasered eye 4 times/day for 4.5 days |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Coordinator | Stanford University | 6507236995 | mnunez1@stanford.edu |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C025494 | 1(beta)-D-arabinofuranosylcytosine-5'-diphosphate prednisolone |
| C009935 | prednisolone acetate |
| D020910 | Ketorolac |
| D004008 | Diclofenac |
| D065346 | Lubricant Eye Drops |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Ketorolac | Drug | Ketorolac 0.5% to lasered eye 4 times/day for 4.5 days |
|
|
| Artificial Tears | Drug | Artificial saline tears to lasered eye 4 times/day for 4.5 days |
|
|
| Pittsburgh |
| Pennsylvania |
| 15213 |
| United States |
| BG002 | Steroid | Prednisolone 1%: Prednisolone 1% to lasered eye 4 times/day for 4.5 days |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Diclofenac 0.1%: Diclofenac sodium 0.1% to lasered eye 4 times/day for 4.5 days
| OG002 | Steroid | Prednisolone 1%: Prednisolone 1% to lasered eye 4 times/day for 4.5 days |
|
|
| Secondary | Intraocular Inflammation | The count of patients with inflammation defined as anterior chamber cells was measured in each study arm. | 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). | Posted | Count of Participants | Participants | Up to week 12 |
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | Non-steroidal Anti-inflammatory | Diclofenac 0.1%: Diclofenac sodium 0.1% to lasered eye 4 times/day for 4.5 days | 0 | 29 | 0 | 29 |
| EG002 | Steroid | Prednisolone 1%: Prednisolone 1% to lasered eye 4 times/day for 4.5 days | 0 | 37 | 0 | 37 |
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| D006571 | Heterocyclic Compounds |
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D009883 | Ophthalmic Solutions |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D054327 | Lubricants |
| D020313 | Specialty Uses of Chemicals |