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临床试验/NCT03064984
NCT03064984Unknown不适用

Blood Based Eyedrops From Different Sources in the Treatment of Severe Keratopathy - A Randomized Clinical Trial

IRCCS Azienda Ospedaliero-Universitaria di Bologna6 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年1月30日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
6
主要终点
Variation of corneal epithelium damage

研究概览

简要总结

Topical preparations (eye drops) derived from the blood have become a relatively common treatment for more advanced forms of keratopathy. The purpose of this study is to evaluate the effect of two blood components from donors (serum cord blood and serum from adult subject donor peripheral blood) in the treatment of severe keratopathies.

详细描述

The rationale for the use of eye drops prepared from the blood as a source is mainly based on their content in growth factors (Growth factors, GF), which play an important role in regulation of many processes involved in normal healing of damaged corneal epithelium . The most used product so far is the eye drop prepared from serum (Autologous Serum, AS) or from platelet-rich plasma (Plasma Rich Platelet, PRP) of peripheral blood taken from the patients themselves. More recently, treatments were introduced by homologous sources that undoubtedly offer advantages as compared to autologous sources. In particular the homologous sources show:

  • not invasiveness to the patient, who could in time not like the repeated withdrawals

  • applicability even in patients with underlying systemic conditions. They may contain in their blood, among others, higher levels of pro-inflammatory factors, with the consequence of poor and inappropriate final product to be prepared and delivered to the eye

  • reliability, since the homologous products can be prepared, controlled, also validated under the microbiological profile and standardized advance, then kept frozen until the dispensation

  • conceptually unlimited availability of the product to be dispensed

  • versatility of therapeutic indications, based on different GF levels which are estimated in advance

The purpose of this study is to evaluate the effect of two products derived from two different blood sources (cord blood collected at birth from placenta umbilical veins and adult subject donor peripheral blood) in the treatment of severe keratopathies.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

The products under study are prepared, standardized, controlled and sealed in anonymous frozen vials in the Transfusional Service of the S.Orsola-Malpighi Hospital, our partner and collaborator in the study. The products have same physical and colour characteristics and cannot be visually recognized. Boxes containing the vials report a code of assignement only known by the Transfusion service personnel.

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

  • diagnosis of severe dry eye , scored as level severity 3 according to the Dry Eye WorkShop grade (DEWS, Ocular Surf 2007)
  • corneal epithelial damage, stained with fluorescein as vital dye, NEI (national Eye Institute) score> 6 (estimated with imageJ software) damage coverage> 25% of total corneal area
  • good general health condition
  • ability to adhere to treatment and to the procedures provided by the study

排除标准

  • concurrent treatment with hypotensive drugs
  • ocular surgery in the 12 months preceding enrollment .

结局指标

主要结局

Variation of corneal epithelium damage

时间窗: 30 days

The effect of the treatment(s) will be evaluated by measuring the area of damaged corneal epithelium (calculated as the mm2 of damaged epithelium) after treatment as compared to baseline, and defined as 1. complete healing : no detection of damaged area; 2. Partial healing : reduction of the damaged corneal area after treatment as compared to baseline ; 3. No improvement : same damaged corneal epithelial area in mm2 at baseline and after treatment; 4. Worsening : damaged corneal epithelial area in mm2 after treatment larger than at baseline

次要结局

  • Variation of subjective sensation of discomfort(30 days)

研究者

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

Emilio C Campos

Full Professor of Ophthalmology, Head Ophthalmology Unit, University of Bologna

IRCCS Azienda Ospedaliero-Universitaria di Bologna

研究点 (6)

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