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NCT Number: NCT06989827

Impact of DED on the Accuracy of Preoperative Keratometry Values in the Calculation of IOL Power for Cataract Surgery.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Preservative free artificial tear

Drug

After diagnosing patients with dry eye disease we prescribed them preservative free artificial tears and scheduled them for a follow-up keratometry.

Primary outcomes

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

    Time frame: pre-surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Stjepan Pinotić, MD

CONTACT

[email protected]

00385977493252

Sponsors and collaborators

Lead sponsor

University Hospital Sestre Milosrdnice

Other

Registry information

Official study 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.

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
May 25, 2025
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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