An interventional study of Eyelid closure for 3 minutes in Dry Eye and Ocular Surface Disease, sponsored by Vienna Institute for Research in Ocular Surgery. Recruiting at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-22.
Sponsored by Vienna Institute for Research in Ocular Surgery · Not applicable, Interventional, and Diagnostic
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.
1,366 studies on the registry are indexed under Dry Eye Syndromes; 207 are open to participants now.
This study's planned enrollment of 29 is below the median of 60 across 1,129 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Vienna Institute for Research in Ocular Surgery is the lead sponsor of 65 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The following measurements will be performed in the mentioned order during the visit 1 only in the randomized study eye: 1. First and second biometry using IOLMaster® 700 (2x, 3 minutes pause between the measurements, eyes open, normal blinking) 2. Eyelid closure for 3 minutes 3. Third biometry using IOLMaster® 700 (1x) right after opening of the eyelid 4. Eyelid closure for 3 minutes 5. 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.
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
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
Plan to share: Undecided — The data that support the findings of this study are available after study completion from the corresponding author upon reasonable request.
No publications or documents are linked to this record.
Started Nov 2024 (actual). Primary completion is estimated for Dec 2025, 13 months after the start.
Of 199 non-industry interventional studies with no phase under Dry Eye Syndromes, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 25. This study's planned 13 months is close to that.
Counting every sponsor, half of 312 studies reached it within 10 months; a quarter within 4 and three quarters within 18.
How these figures are worked out, and which studies are left out of them.
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Vienna Institute for Research in Ocular Surgery