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

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

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.

Study Overview

• Status: Completed
• Conditions: Eye Diseases
• Intervention / Treatment: Device: Lacrimera

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1140
    • Vienna Institute for Research in Ocular Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Group 1; 15 patients will be included in group 1 (no additional treatment)
EXPERIMENTAL: Group 2; 15 patients will be in group 2 (treatment directly after cataract surgery in the surgical theatre)	Device: Lacrimera; 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.
EXPERIMENTAL: Group 3; 15 patients will receive treatment after local anaesthesia (pre-operatively) and directly after cataract surgery (group 3)	Device: Lacrimera; 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.

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

Collaborators and Investigators

• Sponsor: Vienna Institute for Research in Ocular Surgery

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 14, 2021
• Primary Completion (ACTUAL): September 10, 2021
• Study Completion (ACTUAL): September 10, 2021

Study Registration Dates

• First Submitted: August 31, 2021
• First Submitted That Met QC Criteria: September 21, 2021
• First Posted (ACTUAL): October 1, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 1, 2021
• Last Update Submitted That Met QC Criteria: September 21, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lens Diseases; Eye Diseases; Cataract; Capsule Opacification
• Other Study ID Numbers: Lacrimera Staining

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No