Eye Diseases
Conditions
Brief summary
Aim of this study is to evaluate the effect of treatment with Lacrimera® on calculated IOL power prior to cataract surgery and on the stability of ocular surface parameters compared to preservative-free, Hyaluronic-acid containing eyedrops (Hylo-Vision® sine).
Detailed description
The present study seeks to investigate the effect of treatment with Lacrimera® on the calculated IOL power prior to cataract surgery and on the stability of ocular surface parameters compared to preservative-free, Hyaluronic-acid containing eyedrops (Hylo-Vision® sine).
Interventions
DEVICELacrimera
A new preservative-free formulation of eye drops consists of a novel biopolymer, chitosan-N-acetylcysteine (C-NAC; Lacrimera®, Croma-Pharma GmbH, Leobendorf, Austria), which electrostatically binds to the mucine layer of the tear film forming a glycocalyx-like structure.
DEVICEHylo-Vision
Preservative-free, Hyaluronic-acid containing eyedrops (Hylo-Vision® sine)
Sponsors
Vienna Institute for Research in Ocular Surgery
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
All study-related measurements will be performed by a masked observer.
Intervention model description
After enrolment into the study three study visits will be scheduled. The selection of the study eye will be randomized using www.randomizer.org. The contralateral eye serves as the control eye. After the baseline examination and the follow-up examination one hour later, patients will be released with a prescription of one drop of Lacrimera® into the study eye per day in the evening and with one drop of single-use preservative-free hyaluronic acid containing eye drops (Hylo-Vision® sine) into the control eye three times a day for 14 consecutive days.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age older than 18 years * Corneal staining (marked to severe; NEI grading scale \>=10)
Exclusion criteria
* Usage of eye drops other than lubricants (e.g. antibiotics, steroids, cyclosporin-A) * Usage of systemic antibiotic therapy 7 * Any pathology of the ocular surface except dry eye disease (e.g. corneal scarring, cornea ectasia) * Ocular surgery within prior 3 months * Preceding refractive surgery (e.g. LASIK) * Ocular injury within prior 3 months * Ocular herpes of eye or eyelid within prior 3 months * Active ocular infection * Active ocular inflammation or history of chronic, recurrent ocular inflammation within prior 3 months * Eyelid abnormalities that affect lid function * Ocular surface abnormality that may compromise corneal integrity * Pregnancy and nursing women (in women of childbearing age a pregnancy test will be performed before inclusion into the study)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Spherical and toric IOL power | 1 hour | Spherical and toric IOL power selected at baseline |
| Difference in spherical and toric IOL power | 2 weeks | Difference in spherical and toric IOL power between baseline and the 2 weeks visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reproducibility of biometry readings | 2 weeks +/- 2 days | Reproducibility of biometry readings at each study visit (Baseline, 1 hour after Baseline, after 1 week, after 2 weeks) * Axial length * Keratometry readings (K1, K2) |
| Change of dry eye parameters | 2 weeks +/- 2 days | Change of dry eye parameters between baseline and 2 weeks * BUT (fluorescein and non-invasive BUT) * NEI grading score |
| Difference between study and control eye | 2 weeks +/- 2 days | Difference between study and control eye (baseline and 2 weeks) * BUT (fluorescein and non-invasive BUT) * NEI grading score |
Countries
Austria
Outcome results
None listed