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| Name | Class |
|---|---|
| Consortium for Medical Marijuana Clinical Outcomes Research | OTHER |
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Photorefractive Keratectomy (PRK) is a commonly performed corneal refractive surgery but has significant post-operative pain. Pain medications after PRK are typically opioid-acetaminophen combinations. Alternatives to opioid medication are worth consideration. Patients will receive PRK in each eye sequentially, using the cannabinoid or codeine/acetaminophen for one eye and the other treatment for the fellow eye two weeks later.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral cannabinoid | Experimental | Oral cannabinoid |
|
| Oral codeine/acetaminophen | Active Comparator | Oral codeine-acetaminophen for controlling pain |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oral cannabinoid | Drug | dronabinol |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain as Recorded by the FACES Scale (Maximum) After First Surgery | The Wong-Baker Faces Pain Rating Scale is a pain scale that was developed by Donna Wong and Connie Baker. The scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable" | 1 week after first surgery |
| Pain as Recorded by the FACES Scale (Maximum) After Second Surgery | The Wong-Baker Faces Pain Rating Scale is a pain scale that was developed by Donna Wong and Connie Baker. The scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable" | 1 week after second surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Uncorrected Visual Acuity of First Eye Surgery | Uncorrected visual acuity as measured by Snellen Chart | 3 months after first surgery |
| PROWL-SS | An online questionnaire derived from the Patient-Reported Outcomes With LASIK (PROWL) will be given to patients after PRK at 3 months. It ranges from 0-100, where 100 indicates best possible vision and satisfaction, while 0 indicates worst possible vision and satisfaction. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| W Steigleman, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida Oaks Eye Center | Gainesville | Florida | 32605 | United States |
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Any patient who could not undergo surgery due to contraindications such as thin cornea, irregular astigmatism, or inability to lay flat were excluded. Patients who could not undergo sequential eye surgery due to scheduling constraints could not enroll in the study.
Thirty-five myopic patients were recruited and had surgery for both eyes completed between 1/1/2024 and 12/31/2024. Patients seeking refractive surgery and who were candidates for photorefractive keratectomy were approached with the option to enroll in the ophthalmology clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 | Group 1 patients were assigned to take CBD 50mg 2x/day by mouth for 1 week after surgery on the first eye and Tylenol T3 30-300mg 3x/day by mouth for 1 week after surgery on the fellow eye. |
| FG001 | Group 2 | Group 2 patients were assigned to take Tylenol T3 30-300mg 3x/day by mouth for 1 week after surgery on the first eye and CBD 50mg 2x/day by mouth for 1 week after surgery on the fellow eye. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Preoperative |
| |||||||||||||
| POW1 |
| |||||||||||||
| POM1 |
| |||||||||||||
| POM3 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | Group 1 patients had 50mg CBD chemovar twice a day by mouth after their first photorefractive surgery on one eye, then later had Tylenol T3 30-300mg three times a day by mouth after their second surgery on the fellow eye. |
| BG001 | Group 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Because patients were their own controls, age is unchanged across groups. |
| 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 | Pain as Recorded by the FACES Scale (Maximum) After First Surgery | The Wong-Baker Faces Pain Rating Scale is a pain scale that was developed by Donna Wong and Connie Baker. The scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable" | Posted | Mean | Standard Deviation | units on a scale | 1 week after first surgery |
|
3 months
Patients are not expected to die from photorefractive keratectomy nor are serious adverse events generally expected.
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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 | Cannabidiol | Patients given 50mg CBD chemovar twice a day by mouth after photorefractive surgery on one eye. Depending on study group, this may be after the first or second surgery. |
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This study could not separate the effects of long-term vision quality of life outcomes between drugs, although these secondary outcomes are only for safety monitoring and not for comparing drug effects.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yujia Zhou | University of Florida Oaks Eye Center | 3522652020 | yzhou1996@ufl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 22, 2024 | May 18, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 22, 2024 | May 18, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 18, 2023 | May 18, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D006956 | Hyperopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013759 | Dronabinol |
| C526278 | acetaminophen, codeine drug combination |
| ID | Term |
|---|---|
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| oral codeine/acetaminophen | Combination Product | 10 tablets of acetaminophen-codeine combination (300-30mg) without refills. |
|
| 3 month |
| Quality of Life Refractive Correction Survey | The QIRC measures quality of life associated with vision and eyewear problems, measured at 3 months. It ranges from 0-100, where 0 indicates best possible vision and quality of life and 100 indicates worst possible vision and quality of life. | 3 months |
| Ocular Discomfort Questionnaire | An online questionnaire derived from the Ocular Surface Disease Index (OSDI) at 3 months. It ranges from 0-48, where 0 indicates no eye discomfort and 48 indicates constant, debilitating, worst-possible eye discomfort or pain. | 3 months |
| Uncorrected Visual Acuity of Second Eye Surgery | Uncorrected visual acuity as measured by Snellen Chart | 3 months after second surgery |
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|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
Group 2 patients had Tylenol T3 30-300mg three times a day by mouth after their first photorefractive surgery on one eye, then later had 50mg CBD chemovar twice a day by mouth after their second surgery on the fellow eye. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Because patients were their own controls, demographics are unchanged across groups. | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Not recorded. | Count of Participants | Participants | No |
|
| Visual Acuity | Vision measured for the eye operated on under each drug. | Crossover study, so participants were their own controls. | Mean | Standard Deviation | LogMAR |
|
|
|
|
| Primary | Pain as Recorded by the FACES Scale (Maximum) After Second Surgery | The Wong-Baker Faces Pain Rating Scale is a pain scale that was developed by Donna Wong and Connie Baker. The scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable" | Posted | Mean | Standard Deviation | units on a scale | 1 week after second surgery |
|
|
|
|
| Secondary | Uncorrected Visual Acuity of First Eye Surgery | Uncorrected visual acuity as measured by Snellen Chart | Posted | Mean | Standard Deviation | LogMAR | 3 months after first surgery |
|
|
|
|
| Secondary | PROWL-SS | An online questionnaire derived from the Patient-Reported Outcomes With LASIK (PROWL) will be given to patients after PRK at 3 months. It ranges from 0-100, where 100 indicates best possible vision and satisfaction, while 0 indicates worst possible vision and satisfaction. | Surveys assess overall quality of life which cannot be specifically attributed to a single eye since vision is binocular. For example, having excellent vision in one eye and poor vision in the other can be more disturbing than having poor vision in both eyes or cause patients to suffer from double vision. Because all survey measurements are implied to be binocular at 3 months after both surgeries are done, results are displayed by group instead of intervention. There is no separate measurement. | Posted | Mean | Standard Deviation | score on a scale | 3 month |
|
|
|
|
| Secondary | Quality of Life Refractive Correction Survey | The QIRC measures quality of life associated with vision and eyewear problems, measured at 3 months. It ranges from 0-100, where 0 indicates best possible vision and quality of life and 100 indicates worst possible vision and quality of life. | Surveys assess overall quality of life which cannot be specifically attributed to a single eye since vision is binocular. For example, having excellent vision in one eye and poor vision in the other can be more disturbing than having poor vision in both eyes or cause patients to suffer from double vision. Because all survey measurements are implied to be binocular at 3 months after both surgeries are done, results are displayed by group instead of intervention. There is no separate measurement. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
|
| Secondary | Ocular Discomfort Questionnaire | An online questionnaire derived from the Ocular Surface Disease Index (OSDI) at 3 months. It ranges from 0-48, where 0 indicates no eye discomfort and 48 indicates constant, debilitating, worst-possible eye discomfort or pain. | Surveys assess overall quality of life which cannot be specifically attributed to a single eye since vision is binocular. For example, having excellent vision in one eye and poor vision in the other can be more disturbing than having poor vision in both eyes or cause patients to suffer from double vision. Because all survey measurements are implied to be binocular at 3 months after both surgeries are done, results are displayed by group instead of intervention. There is no separate measurement. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
|
| Secondary | Uncorrected Visual Acuity of Second Eye Surgery | Uncorrected visual acuity as measured by Snellen Chart | Posted | Mean | Standard Deviation | LogMAR | 3 months after second surgery |
|
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | Tylenol T3 | Patients given Tylenol T3 30-300mg three times a day by mouth after photorefractive surgery on one eye. Depending on study group, this may be after the first or second surgery. | 0 | 35 | 0 | 35 | 0 | 35 |
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