Not provided
Not provided
Not provided
Not provided
Not provided
Medical device expired
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eye 1 | Experimental | 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. |
|
| Eye 2 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lacrimera | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Spherical and toric IOL power | Spherical and toric IOL power selected at baseline | 1 hour |
| Spherical and toric IOL power | Spherical and toric IOL power selected at the 2 weeks visit | 2 weeks |
| Difference in spherical and toric IOL power | Difference in spherical and toric IOL power between baseline and the 2 weeks visit | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Reproducibility of biometry readings | Reproducibility of biometry readings at each study visit (Baseline, 1 hour after Baseline, after 1 week, after 2 weeks)
| 2 weeks +/- 2 days |
| Change of dry eye parameters |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Oliver Findl, PrimUnivPrDr | Vienna Institute for Research in Ocular Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vienna Institute for Research in Ocular Surgery | Vienna | 1140 | Austria |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
All study-related measurements will be performed by a masked observer.
Not provided
|
| Hylo-Vision | Device | Preservative-free, Hyaluronic-acid containing eyedrops (Hylo-Vision® sine) |
|
Change of dry eye parameters between baseline and 2 weeks
|
| 2 weeks +/- 2 days |
| Difference between study and control eye | Difference between study and control eye (baseline and 2 weeks)
| 2 weeks +/- 2 days |