Skip to main content
OpenTrials
Completed

NCT Number: NCT05064189

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vienna Institute for Research in Ocular Surgery

Vienna, 1140, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Difference in National Eye Institute Grading Scale (NEI Score)

    Time frame: Day 0

    Difference in National Eye Institute Grading Scale (NEI Score) between baseline and 1 hour post cataract surgery

Secondary outcomes

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

    Time frame: 7 days +/- 1 day

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

  2. 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 break-up time and non-invasive break-up time between the groups at all visits

  3. Difference in NEI Score between the groups at all visits

    Time frame: 7 days +/- 1 day

    Difference in NEI Score between the groups at all visits

  4. Subjective complaints using OSDI score

    Time frame: 7 days +/- 1 day

    Subjective complaints in the 3 groups using OSDI score

  5. 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 break-up time and non-invasive break-up time between baseline and 1 week post-operatively in the different groups

  6. Difference in number of MMP-9 positive eyes

    Time frame: 7 days +/- 1 day

    Difference in number of MMP-9 positive eyes before surgery and 1 week after surgery in the different groups

  7. Subjective complaints using VAS

    Time frame: 7 days +/- 1 day

    Subjective complaints in the 3 groups using VAS

Sponsors and collaborators

Lead sponsor

Vienna Institute for Research in Ocular Surgery

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 1, 2021
Registry last updated
Oct 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.