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PURPOSE: Scleral buckle surgery is a widely used ophthalmic surgery for the correction of rhegmatogenous retinal detachment. Studies suggest that eye pain is a common and underestimated occurrence after scleral buckle surgery, but as of yet, there is no definitive management method for reducing pain following scleral buckle surgery. The investigators aim to control pain following scleral buckle surgery with sub-tenon's irrigation with triamcinolone acetonide at the time of surgery. Using a randomized prospective clinical study, the investigators test if this technique will reduce the pain, nausea/vomiting, and analgesic use caused by scleral buckle surgery.
METHODS: Forty-eight patients undergoing scleral buckle surgery will be randomized into two groups. The experimental group receives a sub-tenon irrigation of 1 cc 40mg/mL triamcinolone acetonide around the base of the scleral buckle (0.25 cc in each quadrant) at time of operation. The control group does not receive any triamcinolone irrigation. Pain scores are measured 1 day post-operatively via 11-pt numerical rating scale as the primary outcome. The nausea/vomiting score is measured 1 day post-operatively via standard 6-pt scale. Patients track pain medication use via pill count. Values will be measured again at 1-2-week and 6 months post-op.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | No additional drug given | |
| Experimental (Triamcinolone Acetonide) | Experimental | receives a sub-tenon irrigation of 1 cc 40mg/mL triamcinolone acetonide around the base of the scleral buckle (0.25 cc in each quadrant) at time of operation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triamcinolone Acetonide 40mg/mL | Drug | Sub-tenon irrigation 1cc |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post Operative Pain Day 1 | 11-point Numerical Rating Scale (0-10, 10 being highest level of pain) | 1 Day Post-Op |
| Measure | Description | Time Frame |
|---|---|---|
| Post Operative Pain Week 1 | 11-point Numerical Rating Scale (0-10, 10 being highest level of pain) | 1 Week Post-Op |
| Pain Medication Use (Tylenol in mg) | Amount of Tylenol used (in mg) cumulatively over one week after the operation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vishak J John, MD | Virginia Tech, Vistar Eye Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vistar Eye Centers | Roanoke | Virginia | 24019 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | No additional drug given |
| FG001 | Experimental (Triamcinolone Acetonide) | receives a sub-tenon irrigation of 1 cc 40mg/mL triamcinolone acetonide around the base of the scleral buckle (0.25 cc in each quadrant) at time of operation Triamcinolone Acetonide 40mg/mL: Sub-tenon irrigation 1cc |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | No additional drug given |
| BG001 | Experimental (Triamcinolone Acetonide) | receives a sub-tenon irrigation of 1 cc 40mg/mL triamcinolone acetonide around the base of the scleral buckle (0.25 cc in each quadrant) at time of operation Triamcinolone Acetonide 40mg/mL: Sub-tenon irrigation 1cc |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| 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 | Post Operative Pain Day 1 | 11-point Numerical Rating Scale (0-10, 10 being highest level of pain) | Posted | Mean | Inter-Quartile Range | score on a scale | 1 Day Post-Op |
|
6 months after experimental treatment
There is no risk for mortality from the use of FDA approved intraocular steroids, no such event has ever been reported
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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 | Control | No additional drug given | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Vishak John | Virginia Tech | (540) 855-5100 | vishakjohn@vt.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 20, 2019 | Jul 11, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012163 | Retinal Detachment |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D014222 | Triamcinolone Acetonide |
| ID | Term |
|---|---|
| D014221 | Triamcinolone |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Cumulative amount used was assessed at one week after operation |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Post Operative Pain Week 1 | 11-point Numerical Rating Scale (0-10, 10 being highest level of pain) | Posted | Mean | Inter-Quartile Range | score on a scale | 1 Week Post-Op |
|
|
|
| Secondary | Pain Medication Use (Tylenol in mg) | Amount of Tylenol used (in mg) cumulatively over one week after the operation | Posted | Mean | Inter-Quartile Range | milligrams | Cumulative amount used was assessed at one week after operation |
|
|
|
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Experimental (Triamcinolone Acetonide) | receives a sub-tenon irrigation of 1 cc 40mg/mL triamcinolone acetonide around the base of the scleral buckle (0.25 cc in each quadrant) at time of operation Triamcinolone Acetonide 40mg/mL: Sub-tenon irrigation 1cc | 0 | 9 | 0 | 9 | 0 | 9 |
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| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |