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NCT Number: NCT07297849

Eyelid Closure in Keratometry

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Eyelid closure for 3 minutes

Behavioral

Patients will be advised to close their eyes for 3 minutes before the third and before the fourth study measurement.

Primary outcomes

  1. Difference in discordant pairs of keratometry quality warnings between the first and third measurement

    Time frame: 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

    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

Study contacts

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

Andreas Schlatter, MD

CONTACT

[email protected]

+43 1 91021 57564

Sponsors and collaborators

Lead sponsor

Vienna Institute for Research in Ocular Surgery

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 22, 2025
Registry last updated
Dec 22, 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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