The Influence of Cataract Surgery on Corneal Biomechanical Properties in Patients With Pseudoexfoliation Syndrome: A Prospective Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in corneal hysteresis (CH)
研究概览
简要总结
Pseudoexfoliation syndrome is associated with alterations in the biomechanical properties of the cornea. This prospective observational cohort study aims to evaluate changes in corneal biomechanical properties after standard phacoemulsification cataract surgery in patients with pseudoexfoliation syndrome compared with patients without pseudoexfoliation syndrome. Corneal hysteresis (CH) and corneal resistance factor (CRF) will be measured using the Ocular Response Analyzer before surgery and at postoperative day 1, day 7, and day 30. The study will enroll patients undergoing routine cataract surgery to compare postoperative changes in CH and CRF between the pseudoexfoliation and control groups.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults aged 50 years and older
- •presence of age-related cataract requiring phacoemulsification cataract surgery
- •presence of pseudoexfoliation syndrome (PEX group) or absence of pseudoexfoliation syndrome (control group)
- •ability and willingness to provide written consent
排除标准
- •previous ocular surgery,
- •corneal disease,
- •glaucoma or ocular hypertension,
- •dry eye disease (Schirmer test <10 mm, tear break-up time <5 seconds or positive fluorescein staining),
- •high refractive error (myopia > -6.00 D or hyperopia > +5.00 D),
- •unilateral pseudoexfoliation when the eye scheduled for surgery showed Adults no signs of PEX,
- •intraoperative or postoperative complications,
- •any ocular disease that could influence corneal biomechanics
研究组 & 干预措施
Pseudoexfoliation syndrome
Patients with clinically diagnosed pseudoexfoliation syndrome undergoing standard phacoemulsification cataract surgery. Corneal hysteresis (CH) and corneal resistance factor (CRF) will be measured preoperatively and on postoperative day 1, day 7 and day 30.
Control
Patients without pseudoexfoliation syndrome undergoing standard phacoemulsification cataract surgery. Corneal hysteresis (CH) and corneal resistance factor (CRF) will be measured preoperatively and on postoperative day 1, day 7 and day 30.
结局指标
主要结局
Change in corneal hysteresis (CH)
时间窗: Baseline, postoperative day 1, day 7 and day 30
Change in corneal hysteresis measured by Ocular response analyzer before cataract surgery and at postoperative day 1, day 7 and day 30. Changes will be compared between patients with pseudoexfoliation syndrome and controls.
次要结局
- Change in corneal resistance factor (CRF)(Baseline, postoperative day 1, day 7 and day 30)
研究者
Kata Culina
Principal investigator, Ophthalmologist
Eye Clinic Medic Zuljan Jukic