Clinical trial
Preservative-free Topical Anesthetics for the Management of Postoperative Pain Following Photorefractive Keratectomy
Name
PFTAPRK
Description
The goal of this interventional comparative study is to assess the efficacy and safety of a novel regimen of preservative-free unit-dose topical anesthetics for controlling early postoperative pain following single-step transepithelial PRK surgery.
The main research questions to answer are:
* Question 1: Are topical anesthetics effective in reducing post-PRK pain?
* Question 2: Are short-term topical anesthetics toxic to the cornea?
* Question 3: How to prevent abuse of topical anesthetics by patients at home?
Participants were planned to undergo a bilateral single-step transepithelial PRK surgery to correct their refractive errors and received a standard post-PRK treatment regimen for both eyes. Additionally, one eye was offered a preservative-free topical anesthetic as an experimental group and the other eye was offered a preservative-free artificial tear as a control group.
Trial arms
Trial start
2023-01-30
Estimated PCD
2023-04-15
Trial end
2023-04-15
Status
Completed
Phase
Early phase I
Treatment
Preservative-free Benoxinate hydrochloride 0.4% (Benoxidia unit-dose vials [UD], Orchidia pharmaceutical Ind., Egypt)
For each patient, one eye was treated with preservative-free Benoxinate hydrochloride 0.4%.
The prescribed regimen comprises of the instillation of one drop immediately, 2, 4, 6 and 8 hours after the end of surgery.
Every patient was given 5 UD vials only of preservative-free Benoxinate hydrochloride 0.4% at each follow up visit for the next postoperative day usage administered 5 times daily (every 3 hours while awake) for the first 3 postoperative days giving clear instructions to immediately discard the vial after single use.
Arms:
Preservative-free topical anesthetics group
Preservative-free Sodium hyaluronate 0.2% (Polyfresh unit-dose vials [UD], Orchidia pharmaceutical Ind., Egypt).
The other eye was treated with preservative-free Sodium hyaluronate 0.2%. The prescribed regimen comprises of the instillation of one drop immediately, 2, 4, 6 and 8 hours after the end of surgery.
Every patient was given 5 UD vials only of preservative-free Sodium hyaluronate 0.2% at each follow up visit for the next postoperative day usage administered 5 times daily (every 3 hours while awake) for the first 3 postoperative days giving clear instructions to immediately discard the vial after single use.
Arms:
Preservative-free artificial tears group
Size
70
Primary endpoint
Postoperative pain score on the verbal rating scale (VRS)
1 week
Postoperative pain score on the visual analogue scale (VAS)
1 week
Eligibility criteria
Inclusion Criteria:
Patients who are candidate for PRK surgery with
1. Myopia up to - 6 diopters or myopic astigmatism up to - 4 diopters.
2. Corneal thinnest pachymetry of 500 µm
3. Residual stromal bed more than 350 µm after epithelial ablation.
Exclusion Criteria:
Patients with
1. Corneal scars or dry eye disease,
2. Past ocular surgery,
3. History of contact lens wear,
4. Systemic diseases such as diabetes mellitus and autoimmune diseases,
5. History of oral analgesics abuse.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 70, 'type': 'ACTUAL'}}
Updated at
2023-05-24
Organization
Assiut UniversityProduct
Benoxinate hydrochlorideIndication
MyopiaProduct
Sodium hyaluronate 0.2%