Eyelid Closure in Keratometry

The Effect of Eyelid Closure on the Quality Index of Keratometric Measurements: a Non-controlled Interventional Study

Cataract surgery is one of the most common performed surgeries in the world. While in the early beginnings of cataract surgery, visual rehabilitation was the main goal of the procedure, refractive outcome and subsequent relative spectacles independency is gaining increasing importance in patients' demands. Due to the improvements in measurement techniques and prediction formulas, the prediction of postoperative refraction is possible with high accuracy. However, there are still some sources of error that lead to deviations of predicted postoperative refraction. For instance, it was shown that tear film osmolarity, an established biomarker for dry eye disease (DED), plays an important role in preoperative precision of keratometry measurements. Keratometry, the measurement of corneal curvature, is an important part of preoperative biometry. Errors in preoperative keratometry measurements lead to nearly one-to-one deviations from the predicted refraction. Therefore, proper keratometry measurements are a key element in intraocular lens (IOL) power calculations. To counteract the issue of DED in preoperative biometry, the principle of using lubricating eye drops before ocular biometry has been investigated and it was shown that the use of ocular lubricants may lead to increased variability of keratometry measurements. From our clinical observations, another possible mechanism to improve keratometry is eyelid closure for some minutes. In contrast to the long-term use of ocular lubricants to stabilize the tear film, eyelid closure is an easy and fast intervention to possibly improve the precision of keratometry measurements. Additionally, a clinical trial investigating the usage of lubricating eye drops for two weeks found no improvement of variability of keratometry in DED patients.

Therefore, this study aims to investigate the effect of eyelid closure on the quality index of keratometric measurements in patients with a warning for the quality of keratometric measurements. For this purpose, a single study day including 4 repeated measurements (2 without and 2 with lid closure for 3 minutes) using an ocular biometer (IOLMaster700) will be performed.

Study Overview

• Status: Recruiting
• Conditions: Dry Eye; Ocular Surface Disease
• Intervention / Treatment: Behavioral: Eyelid closure for 3 minutes

• Study Type: Interventional
• Enrollment (Estimated): 29
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andreas Schlatter, MD; Phone Number: +43 1 91021 57564; Email: office@viros.at

Study Locations

• Austria
  • Vienna
    • Vienna, Vienna, Austria, 1140
      • Recruiting
      • Vienna Institute for Research in Ocular Surgery (VIROS), Department of Ophthalmology
      • Contact: Manuel Ruiss, MSc; Phone Number: +43 1 91021- 57564; Email: office@viros.at
      • Contact: Email: office@viros.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18 or older
• Written informed consent
• Keratometry quality index "warning"

Exclusion Criteria:

• Severe corneal conditions that may compromise corneal integrity (such as corneal scarring, etc.)
• Pregnancy (pregnancy test will be taken in women of reproductive age), nursing women
• Ocular surgery in the study eye in the three months preceding the study
• Inability of visual fixation (e.g. in patients with nystagmus)
• Inability of eyelid closure (e.g. in patients with facial nerve paralysis)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients with a keratometrical warning index; The following measurements will be performed in the mentioned order during the visit 1 only in the randomized study eye: First and second biometry using IOLMaster® 700 (2x, 3 minutes pause between the measurements, eyes open, normal blinking); Eyelid closure for 3 minutes; Third biometry using IOLMaster® 700 (1x) right after opening of the eyelid; Eyelid closure for 3 minutes; Fourth biometry using IOLMaster® 700 (1x) right after opening of the eyelid

Behavioral: Eyelid closure for 3 minutes; Patients will be advised to close their eyes for 3 minutes before the third and before the fourth study measurement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in discordant pairs of keratometry quality warnings between the first and third measurement	As the outcome is binary (successful measurement vs. measurement with a warning/failed), the difference in discordant pairs of keratometry quality warnings between the first and third measurement	Baseline measurement (time: 0 minutes) to third study measurement (time: approximately after 6 minutes - after 3 minutes of eyelid closure) at the same study day

Collaborators and Investigators

• Sponsor: Vienna Institute for Research in Ocular Surgery

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: December 2, 2025
• First Submitted That Met QC Criteria: December 16, 2025
• First Posted (Actual): December 22, 2025

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: EK 24-111-0824

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The data that support the findings of this study are available after study completion from the corresponding author upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No