Eyelid Closure in Keratometry

NCT ID: NCT07297849

Last Updated: 2025-12-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-07
• Study Completion Date: 2025-12-31

Brief 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. 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

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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:

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

Group Type: EXPERIMENTAL

Eyelid closure for 3 minutes

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vienna Institute for Research in Ocular Surgery

OTHER

Sponsor Role: lead

Responsible Party

Prim. Prof. Dr. Oliver Findl, MBA

Head of Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Vienna Institute for Research in Ocular Surgery (VIROS), Department of Ophthalmology

Vienna, Vienna, Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Andreas Schlatter, MD

Role: CONTACT

Phone: +43 1 91021 57564

Email: office@viros.at

Facility Contacts

Manuel Ruiss, MSc

Role: primary

Role: backup

Other Identifiers

EK 24-111-0824

Identifier Type: -

Identifier Source: org_study_id