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

Vienna Institute for Research in Ocular Surgery45 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Eye Diseases

Interventions

LacrimeraDEVICE

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.

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

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

Locations (1)

Vienna Institute for Research in Ocular Surgery

Vienna, Austria

Outcomes

Primary Outcomes

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

Time frame: Day 0

Secondary Outcomes

Difference in NEI Score between all visits post-operatively in the different groups

Time frame: 7 days +/- 1 day

Difference in break-up time and non-invasive break-up time between the groups at all visits

Time frame: 7 days +/- 1 day

Difference in NEI Score between the groups at all visits

Time frame: 7 days +/- 1 day

Subjective complaints using OSDI score

Subjective complaints in the 3 groups using OSDI score

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.