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临床试验/NCT03739255
NCT03739255Unknown不适用

Treatment of Postoperative Discomfort/Pain and Facilitation of Corneal Reepithelialization After Photorefractive Keratectomy

SynsLaser Kirurgi AS0 个研究点目标入组 20 人开始时间: 2020年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
20
主要终点
Re-epithelialization time

研究概览

简要总结

Photorefractive keratectomy (PRK) or surface ablation is one of the most commonly used surgical procedures to correct refractive errors, which was proved to be safe and effective. In PRK, the corneal epithelium is removed by various techniques such as diluted alcohol, manual debridement, brush, or excimer laser, before the refractive excimer laser ablation of the corneal stroma. Compared to laser in situ keratomileusis (LASIK), the two main drawbacks for PRK are slower visual recovery and discomfort in the immediate postoperative period, due to the epithelial removal.

Corneal healing is a complex process involving cellular interaction and reaction with various molecules (proteases, growth factors, and epithelial and stromal cytokines). Enhanced corneal re-epithelialization may reduce the risk for corneal infection and stromal scarring or melting. Over the past few years, a new type of matrix therapy by ReGeneraTing Agent (RGTA) has provided encouraging results, accelerating the healing of chronic skin ulcers in diabetes or vascular origin. RGTAs mimic the action of heparin sulfate molecules, breaking the negative repair-destruction cycle occurring in chronic lesions and inhibit proteolytic enzymes in vitro. In the domain of ophthalmology, RGTA has been reported to show encouraging results in the treatment of corneal ulcer and dystrophies of various etiologies.

The Cacicol20 is an RGTA that binds to matrix proteins to protect them from proteolysis; the extracellular matrix microenvironment protection improves the production of signals and growth factors needed for tissue healing. It is supplied as a sterile single-dose solution of alpha 1-6 poly-carboxymethyl glucose sulfate described and synthesized as in US Patent Number 6689741, with dextran T40 and 0.9% sodium chloride as excipients. It contains no component of animal or biological origin, and penetrates into the cornea without crossing Descemet´s membrane (no intraocular penetration). The Cacicol20 has been reported to be effective in treatment of neurotrophic ulcers and persistent epithelial defects which were unresponsive to the common treatment approaches. Therefore, we expect that the Cacicol20 may facilitate the corneal re-epithelialization after PRK.

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, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing bilateral PRK surgeries for treatment of refractive error
  • Age over 18 years
  • Refractive stability for at least 2 years

排除标准

  • Ocular pathology, including keratoconus or suspected keratoconus, glaucoma, and epithelial defects
  • Previous corneal surgery
  • Systemic disease that might affect corneal wound healing.

研究组 & 干预措施

Placebo

Placebo Comparator

One drop of conservative free artificial tear (Oculac, Thea Laboratories) will be applied to one eye at the same time when Cacicol20 is instilled to the other eye.

干预措施: Placebo (Device)

Cacicol20

Experimental

One drop of Cacicol20 will be applied 4-6 hours after the surgery, in one of the randomly chosen eye, and thereafter one drop daily until the reepithelialization is completed.

干预措施: Cacicol20 (Device)

结局指标

主要结局

Re-epithelialization time

时间窗: 5 days postoperatively

The patients will be examined daily the changes of reepithelialization area, until the re-epithelialization is complete. The days that takes for complete reepithelialization will be recorded.

次要结局

  • Discomfort during reepithelialization(5 days postoperatively)

研究者

发起方
SynsLaser Kirurgi AS
申办方类型
Other
责任方
Principal Investigator
主要研究者

Aleksandar Stojanovic

Medical Director

SynsLaser Kirurgi AS

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