Cataract, Dry Eye
Conditions
Brief summary
The investigational device is an approved biometry device to perform biometric measurements preoperatively to calculate the needed IOL power. First, two native measurements at the IOL Master will be performed. Thereafter randomly assigned artificial tears are instilled in the eye and biometry will be repeated within 30 seconds, as well as after 2 and 5 minutes. At least 24hours after those measurements, two native measurements at the IOL Master will be performed. Thereafter, the not yet used artificial tears are instilled in the eye and biometry will be repeated within 30 seconds, as well as after 2 and 5 minutes. Examinations will be implemented in accordance with the approved investigational plan on subjects and includes: repeated biometry without and with artificial tear drops.
Interventions
DEVICEHigh viscous artificial tears
Instillation of one drop high viscous artificial tears
DEVICELow viscous artificial tears
Instillation of one drop low viscous artificial tears
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Which eye as well as the order of artificial eye drops will be randomized. Randomization information will be put in a sealed envelope on screening date and opened in operating theatre right before procedure start.
Intervention model description
Biometry will be performed in individuals with age related cataract. Patients will be classified as dry eye or normal eye. Two different artificial tears will be instilled at two time points in a randomized order with a time-lag of at least 24 hours.
Eligibility
Sex/Gender
ALL
Age
40 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
* diagnosed uni- or bilateral age-related cataract * Age 40 to 95 * Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
Exclusion criteria
* Corneal abnormality (Corneal scaring) * usage of artificial tears/eyedrops 24h before the examination * necessity of any topical therapy of the eye (i.e. glaucoma) * active ocular or nasal allergies or corneal or conjunctival infection * abnormality of the nasolacrimal drainage apparatus * dry eye severity level 4 (severe and/or disabling constant discomfort and visual symptoms, marked conjunctival injection, filamentary keratitis, mucus clumping, tear debris, ulceration, trichiasis, keratinization, symblepharon) * lid deformities * Preceding ocular surgery or trauma * Pregnancy * Lactation * Uncontrolled systemic or ocular disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary objective is to determine whether application of highly viscid eye drops in normal eyes leads to a change in keratometry measurements after 30 seconds. | 30 seconds | The change in measured k-values (k, k1, k2 in mm) before and after instillation of artificial eye drops will be calculated |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To determine whether application of highly viscid eye drops in normal eyes leads to a change keratometry measurements after 2 minutes or 5 minutes. These objectives will be assessed analogously to the primary objective. | 2, 5minutes | The change in measured k-values (k, k1, k2 in mm)before and after instillation of artificial eye drops will be calculated |
| To determine whether application of slightly viscid eye drops in normal and in dry eyes leads to a change in keratometry measurements after 30 seconds, 2 minutes or 5 minutes. These objectives will be assessed analogously to the primary objective | 30 seconds, 2 minutes or 5 minutes | The change in measured k-values (k, k1, k2 in mm) before and after instillation of artificial eye drops will be calculated |
| To determine whether application of highly viscid eye drops in dry eyes leads to a change in keratometry measurements after 30 seconds, 2 minutes or 5 minutes. These objectives will be assessed analogously to the primary objective | 30 seconds, 2 minutes or 5 minutes | The change in measured k-values (k, k1, k2 in mm) before and after instillation of artificial eye drops will be calculated |
Countries
Austria
Outcome results
None listed