| NCT ID | NCT07297849 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vienna Institute for Research in Ocular Surgery |
| Condition | Dry Eye |
| Study Type | INTERVENTIONAL |
| Enrollment | 29 participants |
| Start Date | 2024-11-07 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 29 participants in total. It began in 2024-11-07 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07297849 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Dry Eye. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07297849 currently recruiting?
Yes, NCT07297849 is actively recruiting participants. Contact the research team at office@viros.at for enrollment information.
Where is the NCT07297849 trial being conducted?
This trial is being conducted at Vienna, Austria.
Who is sponsoring the NCT07297849 clinical trial?
NCT07297849 is sponsored by Vienna Institute for Research in Ocular Surgery. The trial plans to enroll 29 participants.