Dry EyeNCT07297849
Eyelid Closure in Keratometry
A study testing Eyelid closure for 3 minutes in people with Dry Eye and Ocular Surface Disease, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye, Ocular Surface Disease
- What is being tested?
- Eyelid closure for 3 minutes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteAustria
- Study dates
- 7 Nov 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Written informed consent
- Keratometry quality index "warning"
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Vienna Institute for Research in Ocular Surgery (VIROS), Department of Ophthalmology
Vienna, State of Vienna, 1140
Manuel Ruiss, MSc, +43 1 91021- 57564, office@viros.at
office@viros.at
About this study
Official title: 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.
- Conditions
- Dry Eye, Ocular Surface Disease
- Being tested
- Eyelid closure for 3 minutes
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eyelid closure for 3 minutesBehavioural
Patients will be advised to close their eyes for 3 minutes before the third and before the fourth study measurement.
| Study group | Role | What they receive |
|---|---|---|
| Patients with a keratometrical warning index | Experimental | 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 Receives: Behavioral: Eyelid closure for 3 minutes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start7 Nov 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vienna Institute for Research in Ocular Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07297849
- Sponsor's protocol ID
- EK 24-111-0824
- Status last verified
- Dec 2025
- First submitted
- 2 Dec 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data that support the findings of this study are available after study completion from the corresponding author upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Eyelid Closure on the Quality Index of Keratometric Measurements: a Non-controlled Interventional Study
- ClinicalTrials.gov ID
- NCT07297849
- Acronym / sponsor ID
- EK 24-111-0824
- Conditions
- Dry Eye, Ocular Surface Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Vienna Institute for Research in Ocular SurgeryUniversity, hospital or other
- Study start
- 7 Nov 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with a keratometrical warning index | Experimental | Behavioral: Eyelid closure for 3 minutesThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 or older
- Written informed consent
- Keratometry quality index "warning"
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eyelid closure for 3 minutesPatients will be advised to close their eyes for 3 minutes before the third and before the fourth study measurement. | Behavioural | Patients with a keratometrical warning index |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: Undecided. The data that support the findings of this study are available after study completion from the corresponding author upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eyelid closure for 3 minutes in people with Dry Eye and Ocular Surface Disease, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andreas Schlatter, MD (+43 1 91021 57564, office@viros.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.