Hyperopia, Myopia, Photorefractive Keratectomy
Conditions
Brief summary
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.
Interventions
DRUGoral cannabinoid
dronabinol
COMBINATION_PRODUCToral codeine/acetaminophen
10 tablets of acetaminophen-codeine combination (300-30mg) without refills.
Sponsors
Consortium for Medical Marijuana Clinical Outcomes Research
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Adults older than 18 years with refractive stability for 1 year electing to have PRK surgery * Consenting to participate * Not meeting
Exclusion criteria
will be included in the study population.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain as Recorded by the FACES Scale (Maximum) After First Surgery | 1 week 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 |
| Pain as Recorded by the FACES Scale (Maximum) After Second Surgery | 1 week 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Refractive Correction Survey | 3 months | 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. |
| Uncorrected Visual Acuity of First Eye Surgery | 3 months after first surgery | Uncorrected visual acuity as measured by Snellen Chart |
| Uncorrected Visual Acuity of Second Eye Surgery | 3 months after second surgery | Uncorrected visual acuity as measured by Snellen Chart |
| Ocular Discomfort Questionnaire | 3 months | 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. |
| PROWL-SS | 3 month | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 16 |
| Group 2 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. | 19 |
| Total | 35 |
Baseline characteristics
| Characteristic | Group 1 | Group 2 | Total |
|---|---|---|---|
| Age, Continuous | 34.2 Years STANDARD_DEVIATION 5.2 | 30.6 Years STANDARD_DEVIATION 6.8 | 32.5 Years STANDARD_DEVIATION 6.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 16 Participants | 19 Participants | 35 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 9 Participants | 10 Participants | 19 Participants |
| Sex: Female, Male Male | 7 Participants | 9 Participants | 16 Participants |
| Visual Acuity With glasses or contacts | -0.062 LogMAR STANDARD_DEVIATION 0.085 | 0.026 LogMAR STANDARD_DEVIATION 0.338 | -0.014 LogMAR STANDARD_DEVIATION 0.257 |
| Visual Acuity without glasses or contacts | 1.109 LogMAR STANDARD_DEVIATION 0.452 | 1.290 LogMAR STANDARD_DEVIATION 0.475 | 1.207 LogMAR STANDARD_DEVIATION 0.47 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 35 |
| other Total, other adverse events | 0 / 35 | 0 / 35 |
| serious Total, serious adverse events | 0 / 35 | 0 / 35 |
Outcome results
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
Time frame: 1 week after first surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cannabidiol | Pain as Recorded by the FACES Scale (Maximum) After First Surgery | 1.33 units on a scale | Standard Deviation 0.95 |
| Tylenol T3 | Pain as Recorded by the FACES Scale (Maximum) After First Surgery | 1.27 units on a scale | Standard Deviation 0.89 |
p-value: 0.538Wilcoxon (Mann-Whitney)
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
Time frame: 1 week after second surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cannabidiol | Pain as Recorded by the FACES Scale (Maximum) After Second Surgery | 1.46 units on a scale | Standard Deviation 0.82 |
| Tylenol T3 | Pain as Recorded by the FACES Scale (Maximum) After Second Surgery | 1.79 units on a scale | Standard Deviation 1.12 |
p-value: 0.538ANOVA
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.
Time frame: 3 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cannabidiol | Ocular Discomfort Questionnaire | Pre-op | 4.9 score on a scale | Standard Deviation 5.7 |
| Cannabidiol | Ocular Discomfort Questionnaire | Post-op Month 3 | 4.9 score on a scale | Standard Deviation 4.8 |
| Tylenol T3 | Ocular Discomfort Questionnaire | Pre-op | 4.8 score on a scale | Standard Deviation 5.4 |
| Tylenol T3 | Ocular Discomfort Questionnaire | Post-op Month 3 | 3.9 score on a scale | Standard Deviation 4 |
p-value: 0.725ANOVA
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.
Time frame: 3 month
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cannabidiol | PROWL-SS | Pre-op | 58.0 score on a scale | Standard Deviation 20.1 |
| Cannabidiol | PROWL-SS | Post-op Month 3 | 81.6 score on a scale | Standard Deviation 9 |
| Tylenol T3 | PROWL-SS | Pre-op | 60.9 score on a scale | Standard Deviation 18.3 |
| Tylenol T3 | PROWL-SS | Post-op Month 3 | 85.6 score on a scale | Standard Deviation 6.9 |
p-value: <0.851ANOVA
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.
Time frame: 3 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cannabidiol | Quality of Life Refractive Correction Survey | Pre-op | 37.7 score on a scale | Standard Deviation 6.2 |
| Cannabidiol | Quality of Life Refractive Correction Survey | Post-op Month 3 | 19.2 score on a scale | Standard Deviation 6 |
| Tylenol T3 | Quality of Life Refractive Correction Survey | Pre-op | 37.6 score on a scale | Standard Deviation 10.6 |
| Tylenol T3 | Quality of Life Refractive Correction Survey | Post-op Month 3 | 26.4 score on a scale | Standard Deviation 6.3 |
p-value: <0.543ANOVA
Secondary
Uncorrected Visual Acuity of First Eye Surgery
Uncorrected visual acuity as measured by Snellen Chart
Time frame: 3 months after first surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cannabidiol | Uncorrected Visual Acuity of First Eye Surgery | -0.123 LogMAR | Standard Deviation 0.119 |
| Tylenol T3 | Uncorrected Visual Acuity of First Eye Surgery | -0.054 LogMAR | Standard Deviation 0.169 |
p-value: 0.516ANOVA
Secondary
Uncorrected Visual Acuity of Second Eye Surgery
Uncorrected visual acuity as measured by Snellen Chart
Time frame: 3 months after second surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cannabidiol | Uncorrected Visual Acuity of Second Eye Surgery | -0.051 LogMAR | Standard Deviation 0.16 |
| Tylenol T3 | Uncorrected Visual Acuity of Second Eye Surgery | -0.075 LogMAR | Standard Deviation 0.121 |
p-value: 0.516ANOVA