Trial · NCT05477875
Cannabinoid vs Opioid for Photorefractive Keratectomy Pain Control
NCT05477875, Phase 2, Completed, University of Florida; results first posted 2025-08-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Cannabinoid vs Opioid for Photorefractive Keratectomy Pain Control. Trials, record NCT05477875. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05477875
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cannabinoid vs Opioid for Photorefractive Keratectomy Pain Control
- NCT number
- NCT05477875
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 35 participants, actual
- Lead sponsor
- University of Florida
- Conditions
- Photorefractive Keratectomy, Myopia, Hyperopia
- Interventions
- oral cannabinoid, oral codeine/acetaminophen
- First posted
- 2022-07-28
- Last updated
- 2025-08-07
- Results first posted
- 2025-08-07
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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" |
| Primary | 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 | Uncorrected Visual Acuity of First Eye Surgery | 3 months after first surgery | Uncorrected visual acuity as measured by Snellen Chart |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | Uncorrected Visual Acuity of Second Eye Surgery | 3 months after second surgery | Uncorrected visual acuity as measured by Snellen Chart |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pain as Recorded by the FACES Scale (Maximum) After First Surgery | 1 week after first surgery | units on a scale | MEAN | |
| PRIMARY | Pain as Recorded by the FACES Scale (Maximum) After Second Surgery | 1 week after second surgery | units on a scale | MEAN | |
| SECONDARY | Uncorrected Visual Acuity of First Eye Surgery | 3 months after first surgery | LogMAR | MEAN | |
| SECONDARY | PROWL-SS | 3 month | 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. | score on a scale | MEAN |
| SECONDARY | Quality of Life Refractive Correction Survey | 3 months | 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. | score on a scale | MEAN |
| SECONDARY | Ocular Discomfort Questionnaire | 3 months | 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. | score on a scale | MEAN |
| SECONDARY | Uncorrected Visual Acuity of Second Eye Surgery | 3 months after second surgery | LogMAR | MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Pain as Recorded by the FACES Scale (Maximum) After First Surgery | Cannabidiol | 1.33 | Standard Deviation 0.95 | units on a scale | |
| Pain as Recorded by the FACES Scale (Maximum) After First Surgery | Tylenol T3 | 1.27 | Standard Deviation 0.89 | units on a scale | |
| Pain as Recorded by the FACES Scale (Maximum) After Second Surgery | Cannabidiol | 1.46 | Standard Deviation 0.82 | units on a scale | |
| Pain as Recorded by the FACES Scale (Maximum) After Second Surgery | Tylenol T3 | 1.79 | Standard Deviation 1.12 | units on a scale | |
| Uncorrected Visual Acuity of First Eye Surgery | Cannabidiol | -0.123 | Standard Deviation 0.119 | LogMAR | |
| Uncorrected Visual Acuity of First Eye Surgery | Tylenol T3 | -0.054 | Standard Deviation 0.169 | LogMAR | |
| PROWL-SS | Group 1 | Pre-op | 58.0 | Standard Deviation 20.1 | score on a scale |
| PROWL-SS | Group 2 | Pre-op | 60.9 | Standard Deviation 18.3 | score on a scale |
| PROWL-SS | Group 1 | Post-op Month 3 | 81.6 | Standard Deviation 9.0 | score on a scale |
| PROWL-SS | Group 2 | Post-op Month 3 | 85.6 | Standard Deviation 6.9 | score on a scale |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Preoperative | STARTED | Group 1 | 16 | |
| Preoperative | STARTED | Group 2 | 19 | |
| Preoperative | COMPLETED | Group 1 | 16 | |
| Preoperative | COMPLETED | Group 2 | 19 | |
| Preoperative | NOT COMPLETED | Group 1 | 0 | |
| Preoperative | NOT COMPLETED | Group 2 | 0 | |
| POW1 | STARTED | Group 1 | 16 | |
| POW1 | STARTED | Group 2 | 19 | |
| POW1 | COMPLETED | Group 1 | 16 | |
| POW1 | COMPLETED | Group 2 | 19 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cannabidiol | 0 | 35 |
| Total, all-cause mortality | Tylenol T3 | 0 | 35 |
| Total, other adverse events | Cannabidiol | 0 | 35 |
| Total, other adverse events | Tylenol T3 | 0 | 35 |
| Total, serious adverse events | Cannabidiol | 0 | 35 |
| Total, serious adverse events | Tylenol T3 | 0 | 35 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42524865 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cannabidiol vs Tylenol T3: deaths from any cause | Trial comparisons |
| Cannabidiol vs Tylenol T3: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05477875
GET https://conductscience.org/api/trials/v1/NCT05477875/flow?page=2