Effect of Chitosan-N-Acetylcysteine on IOL-power Prior to Cataract Surgery

Study Overview
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Brief Summary
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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
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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).

Official Title
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Effect of Chitosan-N-Acetylcysteine (Lacrimera®) on IOL-power Prior to Cataract Surgery: a Pilot Study

Conditions
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Eye Diseases

Intervention / Treatment
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* Device: Lacrimera
* Device: Hylo-Vision


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eye 1<br>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. | Device: Lacrimera<br>* 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.<br>|
| Active Comparator: Eye 2<br>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. | Device: Hylo-Vision<br>* Preservative-free, Hyaluronic-acid containing eyedrops (Hylo-Vision® sine)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) Axial length Keratometry readings (K1, K2) | 2 weeks +/- 2 days | 
| Change of dry eye parameters | Change of dry eye parameters between baseline and 2 weeks BUT (fluorescein and non-invasive BUT) NEI grading score | 2 weeks +/- 2 days | 
| Difference between study and control eye | Difference between study and control eye (baseline and 2 weeks) BUT (fluorescein and non-invasive BUT) NEI grading score | 2 weeks +/- 2 days |