Cacicol20® in Corneal Wound Healing and Nerve Regeneration After Phototherapeutic Keratectomy of the Anterior Cornea: A Randomized Double-Blinded Placebo-Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Percentage recovery in subbasal nerve density.
研究概览
简要总结
The objective of this clinical study is to test the efficacy of CACICOL20® (RGTA OTR 4120) in improving wound healing and nerve regeneration in the anterior cornea, in a patient population undergoing therapeutic laser treatment for corneal dystrophy or recurrent corneal erosions.
详细描述
Patients undergoing various surgical treatments of the cornea often suffer from a neural deficit, due to nerves being severed or removed completely during surgery. This can result in pain, impaired epithelial wound healing, reduced tear production, symptoms of dry eye, and loss of ocular surface sensitivity/blink reflex. In addition, surgical wound healing can be accompanied by undesirable formation of scar tissue, which can limit postoperative visual acuity. The investigators' prior clinical experience with patients having undergone surgery of the anterior cornea is that neural recovery is slow and incomplete, while in certain situations scar tissue can form and limit the visual recovery.
In this context, CACICOL20®, a regenerative agent approved for use in healing corneal wounds, presents an interesting opportunity for improving postoperative corneal nerve regeneration and a potentially more rapid restoration of the extracellular matrix environment postoperatively, which can lead to improved neural and visual outcomes.
The investigators will therefore evaluate the efficacy of CACICOL20® in a randomized, double-blinded clinical study, to evaluate its ability to promote corneal nerve regeneration, epithelial wound healing, and ocular surface recovery postoperatively.
Upon inclusion and signing of informed consent, patients undergo preoperative examination. Upon satisfying study criteria, patients are randomized to either treatment or placebo group. Group identity is masked to subjects and to investigators (double-blind). Subjects then undergo therapeutic laser treatment of the cornea in a single clinic, followed by instillation of treatment or placebo in the form of 3 eye drops total (to be given once immediately after surgery, once 2 days after surgery, and a final time 4 days after surgery).
Postoperative eye examinations are conducted on days 2 and 7 and at month 6 and 12. Examinations include clinical measurement of various eye and corneal wound healing parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, 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
- 否
入选标准
- •Signed and dated informed consent,
- •Male or female aged ≥ 18 years,
- •Patient with recurrent erosions or epithelial dystrophies indicated for treatment by phototherapeutic keratectomy of the anterior cornea
排除标准
- •In the affected eye: prior corneal surgery
- •In either eye: active ocular infection, glaucoma, or ocular hypertension
- •General history judged by the investigator to be incompatible with the study (life-threatening patient condition).
- •Known allergic hypersensitivity history to Poly(carboxyMethylGlucoseSulfate) or dextran.
- •Inability of patient to understand the study procedures and thus inability to give informed consent.
- •Participation in another clinical study within the last 3 months.
- •Already included once in this study (can only be included for one treated eye)
- •Specific exclusion criteria for women
- •Known pregnancy (if uncertain pregnancy test will be performed)
- •Lactation
- •Women of childbearing potential without an effective method of contraception (oral contraceptive, intra-uterine device, subcutaneous contraceptive implant, vaginal ring) or women not hysterectomised, post-menopausal or surgically sterilized
结局指标
主要结局
Percentage recovery in subbasal nerve density.
时间窗: 12 months postoperative
Degree of corneal subbasal nerve regeneration at one year postoperative, compared to preoperative level, as measured by clinical laser-scanning in vivo confocal microscopy.
次要结局
- Percentage recovery in subbasal nerve density.(6 months postoperative)
- Percentage of epithelial wound closure.(2 and 7 days postoperative.)
- Postoperative pain score on the Visual Analog Scale.(Postoperative day 2, 7, month 6, 12)
- Corneal haze level.(Postoperative month 6, 12)
- Ocular surface sensitivity measured by Cochet-Bonnet esthesiometry.(Postoperative month 6, 12)
- Tear production level(Postoperative day 7, month 6, 12)
- Tear quality(Postoperative day 7, month 6, 12)
- Improvement in visual acuity(Postoperative day 7, month 6, 12)
- Sub basal nerve density measured by clinical in vivo confocal microscopy(Postoperative 6 and 12 months)
- Epithelial cell density measured by clinical in vivo confocal microscopy(Postoperative 12 months)
- Number of postoperative recurrences of erosions.(Postoperative month 12.)
研究者
Neil Lagali
Associate Professor
Region Östergötland