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

NCT06989827 | Not Yet Recruiting

• 1 other identifier: DED_Cataract_25
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye Disease (DED); Cataract

Keywords

keratometry; IOL; intraocular lens; cataract surgery; dry eye disease; DED

Outcome Measures

Primary Outcomes (1)

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

  pre-surgery

Study Arms (2)

Healthy controls

NO INTERVENTION

Patients with diagnosed dry eye disease

ACTIVE COMPARATOR

Drug: Preservative free artificial tear

Interventions

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.

Patients with diagnosed dry eye disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Sestre Milosrdnice: lead

Study Sites (1)

UHC Sestre Milosrdnice

Zagreb, City of Zagreb, 10000, Croatia

Location

Related Publications (1)

• 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.

  PMID: 37919153 BACKGROUND

MeSH Terms

Conditions

Dry Eye Syndromes; Cataract

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Lens Diseases

Central Study Contacts

Stjepan Pinotić, MD

CONTACT

00385977493252; spinotic@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, ophthalmology resident

Model Details: The study is designed to compare two parallel groups of patients, healthy controls and patients diagnosed with dry eye disease.

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 25, 2025
• Study Start: June 2, 2025
• Primary Completion: September 1, 2025
• Study Completion: March 1, 2026
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)