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临床试验/NCT05331859
NCT05331859Unknown1 期

Topical Insulin Versus Autologous Serum and Enhanced Corneal Epithelial Healing After Keratorefractive Surgeries

Benha University2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2022年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
入组人数
250
试验地点
2
主要终点
Duration for the corneal surface to completely re-epithelialize.

研究概览

简要总结

The aim of the study is to test whether use of topical insulin or autologous serum eye-drops can promote corneal epithelial healing following photorefractive keratectomy (PRK).

详细描述

Topical insulin has been proved recently to enhance the corneal reepithelization rate and manage neurotrophic corneal ulcers unresponsive to conventional treatments. However, its effectiveness on corneal epithelial wound healing in patients who received photorefractive keratectomy (PRK) has not been reported. In this study, we plan to perform a prospective non-randomized study to determine the efficacy and safety of topical insulin as a primary treatment for a corneal epithelial defect in patients undergoing the PRK and compare that to autologous serum eye drops. The study eye will receive either the insulin or the serum eye drops, in addition to the conventional treatment, while the control eye will have the standard treatment. For each eligible candidate, the eye with a higher depth of ablation will be the study eye. If even ablation depth in both eyes, the right eye will be selected. The conventional postoperative eye drops include topical moxifloxacin 0.5% (Vigamox; Alcon Laboratories) four times per day, artificial tears (Systane Ultra; Alcon) every two hours, Dexamethasone 0.1% (Maxidex; Alcon Laboratories) four times daily for one month followed by fluorometholone 0.1% (Efemyo; OrchidiaLaboratories) four times daily for another two to four weeks depending on refraction and haze level. In study eyes, the patients receive either topical insulin eye drops or autologous serum in addition to conventional postoperative eye drops until complete epithelial healing. The duration for the corneal surface to completely re-epithelize, the grade of postoperative corneal haze, the incidence of corneal complications due to delayed surface re-epithelization (e.g. infectious corneal ulcer, corneal melting, sterile corneal ulcer, corneal neovascularization), and the distant corrected visual acuity will be compared between these three groups.

研究设计

研究类型
Interventional
分配方式
Non 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 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • stable refraction of at least one year, normal corneal topography, and a minimum central corneal thickness of 500 μm.

排除标准

  • unstable refraction, dry eye, blepharitis, corneal disease, glaucoma, systemic diseases including infectious and collagen vascular diseases, diabetes, and topographical evidence of keratoconus.

研究组 & 干预措施

conventional

Placebo Comparator

Corneal epithelial wound healing in patients who received photorefractive keratectomy (PRK) treated only with conventional postoperative eye drops.

干预措施: conventional (Drug)

Insulin

Active Comparator

Corneal epithelial wound healing in patients who received photorefractive keratectomy (PRK) treated with topical insulin and conventional postoperative eye drops.

干预措施: Insulin (Drug)

Insulin

Active Comparator

Corneal epithelial wound healing in patients who received photorefractive keratectomy (PRK) treated with topical insulin and conventional postoperative eye drops.

干预措施: conventional (Drug)

Autologous serum eye drops

Active Comparator

Corneal epithelial wound healing in patients who received photorefractive keratectomy (PRK) treated with Autologous serum eye and conventional postoperative eye drops.

干预措施: autologous serum (AS) (Drug)

Autologous serum eye drops

Active Comparator

Corneal epithelial wound healing in patients who received photorefractive keratectomy (PRK) treated with Autologous serum eye and conventional postoperative eye drops.

干预措施: conventional (Drug)

结局指标

主要结局

Duration for the corneal surface to completely re-epithelialize.

时间窗: up to 6 weeks

Grade of postoperative corneal haze

时间窗: 6 weeks

0, completely clear cornea; +0.5, barely visible corneal opacity; +1, reticular subepithelial opacities not interfering with visibility of fine iris details; +2, punctate or coalesced subepithelial opacities with mild obscuration of iris details; +3, confluent subepithelial opacities with moderate obscuration of the iris and lens; and +4, dense opacities with complete opacification of the stroma.

次要结局

  • Best-corrected Visual Acuity improvement (Snellen, decimal)(Before and after treatment completion, assessed up to 6 weeks)
  • Incidence of corneal complications due to delayed surface re-epithelization (e.g. infectious corneal ulcer, sterile corneal ulcer, corneal melting, corneal neovascularization).(6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Taher Eleiwa

Dr

Benha University

研究点 (2)

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