Clinical trial NCT06989827: Impact of DED on the Accuracy of Preoperative Keratometry Values in the Calculation of IOL Power for Cataract Surgery.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dry Eye Disease (DED)
Cataract
Keywords: keratometry
IOL
intraocular lens
cataract surgery
dry eye disease
DED
Lead sponsor: University Hospital Sestre Milosrdnice
Sponsor class: OTHER
First posted: 2025-05-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is designed to compare two parallel groups of patients, healthy controls and patients diagnosed with dry eye disease.
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Variability in keratometric values before and after dry eye disease treatment with preservative free artificial tears
timeFrame: pre-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: UHC Sestre Milosrdnice
state: Grad Zagreb
Study officials:
References:
citation: Yang F, Yang L, Ning X, Liu J, Wang J. Effect of dry eye on the reliability of keratometry for cataract surgery planning. J Fr Ophtalmol. 2024 Feb;47(2):103999. doi: 10.1016/j.jfo.2023.04.016. Epub 2023 Oct 31.