Preservative-free Topical Anesthetics for the Management of Postoperative Pain Following Photorefractive Keratectomy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Postoperative pain score on the verbal rating scale (VRS)
研究概览
简要总结
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.
详细描述
Photorefractive keratectomy (PRK) is a well-established surface ablation procedure for correction of refractive errors which involves the removal of corneal epithelium in a large diameter usually more than 6 mm followed by stromal ablation.
Early postoperative pain within the first few days after surgery is one of the commonest complications reported after PRK. The classic postoperative treatment includes the prescription of topical antibiotics and frequent preservative-free lubricants to accelerate epithelial healing.
The current treatment regimens also includes topical steroids, topical non-steroidal anti-inflammatory drugs (NSAID) and oral NSAID to reduce inflammation and post-PRK pain.
Earlier studies suggested that topical anesthetics in diluted concentrations and fractional doses didn't delay corneal epithelial regeneration after PRK but their use didn't gain popularity because of problems with topical formulation, stability and preservation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Preservative-free topical anesthetics group
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.
干预措施: Preservative-free Benoxinate hydrochloride 0.4% (Benoxidia unit-dose vials [UD], Orchidia pharmaceutical Ind., Egypt) (Drug)
Preservative-free artificial tears group
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.
干预措施: Preservative-free Sodium hyaluronate 0.2% (Polyfresh unit-dose vials [UD], Orchidia pharmaceutical Ind., Egypt). (Drug)
结局指标
主要结局
Postoperative pain score on the verbal rating scale (VRS)
时间窗: 1 week
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).
Postoperative pain score on the visual analogue scale (VAS)
时间窗: 1 week
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.
次要结局
- Corneal epithelial healing duration(1 week)
- Endothelial cell density (ECD)(from preoperative to 1 month postoperative.)
研究者
Mahmoud Abdel-Radi
Principal Investigator
Assiut University