Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04399122 |
| Other study ID # |
FWH20160007H |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
March 21, 2017 |
| Est. completion date |
October 28, 2019 |
Study information
| Verified date |
September 2021 |
| Source |
59th Medical Wing |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Photorefractive keratectomy (PRK) is a refractive error correction procedure that helps
eliminate or reduce the dependence on corrective lenses. An important aspect of PRK is
post-operative pain management. Post-operative pain can be significant in the first three to
five days and is typically controlled utilizing various modalities including narcotic pain
medication. Simple observation suggests a difference in the post-operative pain levels of
patients utilizing the more potent oxycodone- versus the less potent codeine-containing
acetaminophen preparations. There have been no studies performed to explore any differences
in perceived pain comparing these two medications when used following PRK. This study is
designed to answer this question by means of a pain survey conducted in the first five days
post-op. This may help better manage similar patients in the future.
Description:
This will be a prospective pain assessment study utilizing a simple three question survey
given to patients undergoing bilateral PRK. Following recruitment and enrollment (see section
4.1 and 4.2 for recruitment and consent process), patients will be randomized to be
prescribed either 1) Group 1: codeine 30mg/acetaminophen 300mg (standard of care dosage) or
2) Group 2: oxycodone 5mg/acetaminophen 325mg (standard of care dosage) post-operatively. All
post-operative patients will receive standard bandage contact lenses and as needed tetracaine
as per standard of care. Patients will be removed from the study if they take other non-study
pain medications. They will be asked to record their pain levels four times daily as well as
the number of as needed narcotic pain medication taken and the number of tetracaine drops
used (to isolate a potential confounding pain control modality). Randomization will be
performed with the aid of www.randomizer.org which will generate a randomized assignment to
either group 1 or group 2.
All PRK procedures will be performed per standard of care. The procedure will be performed by
one of the 4 approved surgeons. All surgeons will use the same technique using either the
VISX or the Allegretto laser machines. This technique will include use of a brush for
mechanical removal of corneal epithelial cells. The surgeons will take note at this time of
the relative adherence of the epithelium to the underlying tissue and grade the adherence on
a scale of 0-4 (0=least adherent and 4=most adherent). In the data analysis, differences
between surgeons and between operating platform (VISX vs Allegretto) will be compared to
account for any possible bias in operating parameters.
The survey will be worded as follows:
1. "Rate your eye pain or level of discomfort at 0800, 1200, 1600 and 2000. Please write
the number closest to your response in the table below under the appropriate day and
time.
2. "How many tablets of study-related pain medication did you take today in the AM/PM?"
3. "How many times did you use topical tetracaine today in the AM/PM?"
4. "Did you take any other non-study related pain medications?"
Patients will be followed-up post-operatively as per standard of care. This includes
follow-up visits at 1 day, 1 week, 1 month, 3 months, 6 months and 12 months. Starting on
post-operative day 1, the patients will be asked to record their pain levels using the pain
survey at four hour intervals (0800, 1200, 1600, 2000). At the 1 week post-operative visit,
the pain surveys will be collected from the patients. Visual acuity data will be extracted
from all but the 12 month follow-up appointment and used as a secondary outcome to correlate
any possible differences in pain scores to functional outcomes in terms of visual acuity.
