Protein Profile of Immunoregulatory Factors in Diabetic Cataract
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- serum level of monocyte chemotactic protein-1
研究概览
简要总结
The purpose of this study is to compare the levels of several immunoregulatory factors in serums and aqueous humor of type II diabetes cataract patients with those in senile non-diabetic cataract patients since disturbed cytokine and growth factor microenvironment in diabetic eye may contribute to an increased frequency of intraoperative and postoperative intraocular lens surgery complications.
详细描述
The study compared the levels of several immunoregulatory molecules (vascular endothelial growth factor (VEGF), monocyte chemotactic protein-1 (MCP-1), Fas Ligand (FasL), interleukin-10 (IL-10) and interleukin-17 (IL-17)) in serum and aqueous humor between type 2 diabetes mellitus patients, without clinically evident diabetic retinopathy or diabetic macular edema, and nondiabetic cataract patients.
Investigators also investigated whether concentrations of immunoregulatory molecules significantly correlated with intraoperative and postoperative parameters. Particularly, investigators focused on the development of corneal edema as one of the main causes of low visual acuity in the immediate postoperative period after intraocular lens implantation.
Since disturbed cytokine and growth factor microenvironment in diabetic eye may contribute to an increased frequency of intraoperative and postoperative intraocular lens (IOL) surgery complications, the findings may be relevant for the development of therapeutic strategies aimed to restore protein profile of immunoregulatory factors in parallel to cataract treatment.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing phacoemulsification combined with IOL implantation
- •for diabetic group: duration of type 2 diabetes mellitus (T2DM) for 10 to 15 years
- •for diabetic group: therapy with oral hypoglycemic agents for glycemic control
- •no other ocular (retinal) or systemic diabetic complications of T2DM
排除标准
- •patients who had cataract that could result from some other ocular condition, systemic disease (except T2DM for diabetic group) or trauma
- •patients with immune disease, local or systemic inflammation which could affect cytokine concentration in serum or aqueous humor (AH)
研究组 & 干预措施
senile cataract with NSAID
15 non-diabetic patients undergoing phacoemulsification combined with IOL implantation.
Subgroup receiving topical nonsteroidal anti-inflammatory drug (NSAID) ketorolac.
干预措施: Ketorolac (Drug)
diabetic cataract with NSAID
17 diabetic patients undergoing phacoemulsification combined with IOL implantation.
Subgroup receiving topical nonsteroidal anti-inflammatory drug (NSAID) ketorolac.
干预措施: Ketorolac (Drug)
结局指标
主要结局
serum level of monocyte chemotactic protein-1
时间窗: 2 hours before the surgery
serum level of interleukin-17
时间窗: 2 hours before the surgery
serum level of Fas ligand
时间窗: 2 hours before the surgery
serum level of vascular endothelial growth factor
时间窗: 2 hours before the surgery
serum level of interleukin-10
时间窗: 2 hours before the surgery
level of interleukin-10 in aqueous humor
时间窗: intraoperatively, at the start of the surgical procedure
level of monocyte chemotactic protein-1 in aqueous humor
时间窗: intraoperatively, at the start of the surgical procedure
level of interleukin-17 in aqueous humor
时间窗: intraoperatively, at the start of the surgical procedure
level of Fas ligand in aqueous humor
时间窗: intraoperatively, at the start of the surgical procedure
level of vascular endothelial growth factor in aqueous humor
时间窗: intraoperatively, at the start of the surgical procedure
次要结局
- degree of corneal edema(postoperatively - month 3)
研究者
Danka Grcevic
prof. Danka Grcevic, MD, PhD
University of Zagreb