Preservative-free Topical Anesthetics for Post-PRK Pain

NCT05733741 | Completed Phase 4

• 1 other identifier: PFTAPRK
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myopia

Keywords

Post-PRK pain; Preservative-free topical anesthetics; Single-step PRK

Outcome Measures

Primary Outcomes (2)

• Postoperative pain score on the verbal rating scale (VRS)

  The doctor asks the patient to choose the word that best describes his/her pain and then gives it a score from zero to 4 (Zero for no pain, 1 for mild pain, 2 for moderate pain, 3 for severe pain and 4 for unbearable pain).

  1 week

• Postoperative pain score on the visual analogue scale (VAS)

  The patient is asked to rate his/her pain by choosing a number on a scale from zero to 10 considering zero as no pain and 10 as worst possible pain.

  1 week

Secondary Outcomes (2)

• Corneal epithelial healing duration

  1 week

• Endothelial cell density (ECD)

  from preoperative to 1 month postoperative.

Study Arms (2)

Preservative-free topical anesthetics group

EXPERIMENTAL

Patients in this group had the standard post-PRK treatment regimen in addition to the prescription of preservative-free topical anesthetics for pain control following single-step transepithelial PRK surgery in one eye.

Drug: Preservative-free Benoxinate hydrochloride 0.4% (Benoxidia unit-dose vials [UD], Orchidia pharmaceutical Ind., Egypt)

Preservative-free artificial tears group

PLACEBO COMPARATOR

Patients in this group had the standard post-PRK treatment regimen in addition to the prescription of preservative-free artificial tears as a placebo following single-step transepithelial PRK surgery in the other eye.

Drug: Preservative-free Sodium hyaluronate 0.2% (Polyfresh unit-dose vials [UD], Orchidia pharmaceutical Ind., Egypt).

Interventions

Preservative-free Benoxinate hydrochloride 0.4% (Benoxidia unit-dose vials [UD], Orchidia pharmaceutical Ind., Egypt) DRUG

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.

Preservative-free topical anesthetics group

Preservative-free Sodium hyaluronate 0.2% (Polyfresh unit-dose vials [UD], Orchidia pharmaceutical Ind., Egypt). DRUG

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.

Preservative-free artificial tears group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are candidate for PRK surgery with
• Myopia up to - 6 diopters or myopic astigmatism up to - 4 diopters.
• Corneal thinnest pachymetry of 500 µm
• Residual stromal bed more than 350 µm after epithelial ablation.

You may not qualify if:

• Patients with
• Corneal scars or dry eye disease,
• Past ocular surgery,
• History of contact lens wear,
• Systemic diseases such as diabetes mellitus and autoimmune diseases,
• History of oral analgesics abuse.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Tiba Eye Center

Asyut, 71516, Egypt

Location

Related Publications (2)

• Steigleman WA, Rose-Nussbaumer J, Al-Mohtaseb Z, Santhiago MR, Lin CC, Pantanelli SM, Kim SJ, Schallhorn JM. Management of Pain after Photorefractive Keratectomy: A Report by the American Academy of Ophthalmology. Ophthalmology. 2023 Jan;130(1):87-98. doi: 10.1016/j.ophtha.2022.07.028. Epub 2022 Oct 4.

  PMID: 36207168 BACKGROUND

• Abdel-Radi M, Eldaly Z, Alattar S, Goda I. Preservative-Free Topical Anesthetic Unit-Dose Eye Drops for the Management of Postoperative Pain Following Photorefractive Keratectomy. Ophthalmol Ther. 2023 Dec;12(6):3025-3038. doi: 10.1007/s40123-023-00791-0. Epub 2023 Sep 4.

  PMID: 37665497 DERIVED

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Mahmoud Abdel-Radi, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: February 17, 2023
• Study Start: January 30, 2023
• Primary Completion: April 15, 2023
• Study Completion: April 15, 2023
• Last Updated: May 24, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)