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临床试验/NCT06989827
NCT06989827尚未招募不适用

Evaluation of the Influence of Dry Eye Disease on the Precision of Preoperative Keratometry Measurements and Its Effect on Intraocular Lens Power Calculations in Patients Undergoing Cataract Surgery.

University Hospital Sestre Milosrdnice1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年6月2日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
Variability in keratometric values before and after dry eye disease treatment with preservative free artificial tears

研究概览

简要总结

This study looks at how dry eye disease can affect important eye measurements needed before cataract surgery. These measurements guide us in choosing the right artificial lens to implant, which is essential for achieving clear vision after the procedure. We are currently investigating whether patients with dry eyes tend to have less reliable readings due to surface irregularities on the eye. Our goal is to better understand this connection so we can improve pre-surgical preparation for patients with dry eye and help ensure better visual outcomes after cataract surgery.

详细描述

In this study, we are investigating the potential impact of dry eye disease (DED) on the accuracy of preoperative keratometry values used in intraocular lens (IOL) power calculations for cataract surgery. Precise keratometric measurements are essential for determining the appropriate IOL power to achieve optimal postoperative refractive outcomes. However, ocular surface irregularities associated with DED-such as tear film instability, corneal epithelial disruption, and increased surface variability-may compromise the repeatability and reliability of these measurements.

We aim to examine the correlation between the severity of dry eye and the variability or inaccuracy in keratometric readings obtained through standard biometry techniques. Patients undergoing cataract surgery are being prospectively evaluated and stratified based on dry eye status using established diagnostic criteria, including patient-reported symptom questionnaires (OSDI), tear break-up time (TBUT), corneal staining patterns (Oxford grading scale), Schirmer's test values, and Meibomian Gland Evaluation (Meibomian Quality Score). Preoperative keratometry data are collected using optical biometers, and repeated measurements are analyzed for variability. IOL power calculations are compared with postoperative refractive outcomes to assess clinical significance.

By identifying potential discrepancies linked to dry eye severity, we aim to determine whether preoperative DED management could meaningfully improve measurement precision and, consequently, visual outcomes. Preliminary observations suggest that untreated or suboptimally managed DED may lead to inconsistent keratometric values, which in turn could contribute to unexpected postoperative refractive errors.

Our ultimate goal is to provide evidence-based recommendations for preoperative screening and treatment protocols for DED in cataract surgery candidates. These findings could support the development of standardized guidelines that incorporate ocular surface optimization as an essential component of pre-surgical planning, thereby enhancing surgical precision and patient satisfaction.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

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

  • healthy controls scheduled to undergo cataract surgery
  • patients diagnosed with dry eye disease scheduled to undergo cataract surgery

排除标准

  • patients already on therapy regimen using Preservative free artificial tears
  • patients on antihistamines/decongestants, antidepressants, anti-Parkinson's, antipsychotics and antispasmodic medications.

研究组 & 干预措施

Patients with diagnosed dry eye disease

Active Comparator

干预措施: Preservative free artificial tear (Drug)

结局指标

主要结局

Variability in keratometric values before and after dry eye disease treatment with preservative free artificial tears

时间窗: pre-surgery

次要结局

未报告次要终点

研究者

发起方
University Hospital Sestre Milosrdnice
申办方类型
Other
责任方
Principal Investigator
主要研究者

Stjepan Pinotić

Medical Doctor, ophthalmology resident

University Hospital Sestre Milosrdnice

研究点 (1)

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