Protection of Corneal Epithelium Using Chitosan-N-acetylcysteine Eye Drops During and/or After Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess if treatment with Lacrimera® eye drops (Croma-Pharma GbmH, Leobendorf, Austria) during and/ or after cataract surgery has a positive effect on the ocular surface compared to control group.

Detailed Description
-----------------
Prior to surgery, pre-assessment measurements will be performed in the same fashion as for non-study patients. Patients will be randomized to one of the 3 groups in a 1:1:1 fashion using an online randomization tool (www.randomizer.org, list randomizer). Surgery is performed in topical anaesthesia. Right after topical anaesthesia, patients allocated to Group 3 will receive 1 drop of Lacrimera® in the study eye. Injection of viscoelastic substance (OVD), capsulorhexis, phacoemulsification, and coaxial irrigation/ aspiration of cortical material are performed as standard procedure. After IOL implantation the OVD will be removed and at the end of the surgery, stromal hydration will be performed to the incision as a routine procedure to seal the wound. Right after the wound is sealed, patients allocated to group 2 and group 3 will receive 1 drop of Lacrimera® in the study eye. Postoperative standard medication (Bromfenac gtt., twice a day for 4 weeks) will be prescribed for all groups.

Official Title
-----------------
Protection of Corneal Epithelium Using Chitosan-N-acetylcysteine Eye Drops During and/or After Cataract Surgery: a Pilot Study

Conditions
-----------------
Eye Diseases

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 22 or older Scheduled for cataract surgery Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant Written informed consent prior to surgery Exclusion Criteria: Relevant other ophthalmic diseases such as pseudoexfoliation syndrome (PEX), Intraoperative Floppy Iris Syndrome (IFIS), cornea pathology (e.g. corneal scars, etc.) Usage of eye drops other than lubricants (e.g. antibiotics, steroids, cyclosporin-A) Previous ocular surgery or trauma in the study eye within 6 months of the cataract surgery Active ocular infection or inflammation Pregnancy (pregnancy test will be taken in women of reproductive age) Subjects with surgery longer than 30 minutes will be excluded and replaced

Ages Eligible for Study
-----------------
Minimum Age: 22 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Group 1<br>15 patients will be included in group 1 (no additional treatment) | |
| Experimental: Group 2<br>15 patients will be in group 2 (treatment directly after cataract surgery in the surgical theatre) | 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>|
| Experimental: Group 3<br>15 patients will receive treatment after local anaesthesia (pre-operatively) and directly after cataract surgery (group 3) | 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>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in National Eye Institute Grading Scale (NEI Score) | Difference in National Eye Institute Grading Scale (NEI Score) between baseline and 1 hour post cataract surgery | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in NEI Score between all visits post-operatively in the different groups | Difference in NEI Score between all visits post-operatively in the different groups | 7 days +/- 1 day | 
| Difference in break-up time and non-invasive break-up time between the groups at all visits | Difference in break-up time and non-invasive break-up time between the groups at all visits | 7 days +/- 1 day | 
| Difference in NEI Score between the groups at all visits | Difference in NEI Score between the groups at all visits | 7 days +/- 1 day | 
| Subjective complaints using OSDI score | Subjective complaints in the 3 groups using OSDI score | 7 days +/- 1 day | 
| Difference in break-up time and non-invasive break-up time between baseline and 1 week post-operatively in the different groups | Difference in break-up time and non-invasive break-up time between baseline and 1 week post-operatively in the different groups | 7 days +/- 1 day | 
| Difference in number of MMP-9 positive eyes | Difference in number of MMP-9 positive eyes before surgery and 1 week after surgery in the different groups | 7 days +/- 1 day | 
| Subjective complaints using VAS | Subjective complaints in the 3 groups using VAS | 7 days +/- 1 day |