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

NCT05064189 | Completed

• 1 other identifier: Lacrimera Staining
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Eye Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

  7 days +/- 1 day

• Difference in NEI Score between the groups at all visits

  7 days +/- 1 day

• Subjective complaints 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

  7 days +/- 1 day

Study Arms (3)

Group 1

NO INTERVENTION

15 patients will be included in group 1 (no additional treatment)

Group 2

EXPERIMENTAL

15 patients will be in group 2 (treatment directly after cataract surgery in the surgical theatre)

Device: Lacrimera

Group 3

EXPERIMENTAL

15 patients will receive treatment after local anaesthesia (pre-operatively) and directly after cataract surgery (group 3)

Device: Lacrimera

Interventions

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.

Group 2; Group 3

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vienna Institute for Research in Ocular Surgery: lead

Study Sites (1)

Vienna Institute for Research in Ocular Surgery

Vienna, 1140, Austria

Location

MeSH Terms

Conditions

Eye Diseases

Study Officials

• Oliver Findl, PrimUnivPrDr

  Vienna Institute for Research in Ocular Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: October 1, 2021
• Study Start: April 14, 2021
• Primary Completion: September 10, 2021
• Study Completion: September 10, 2021
• Last Updated: October 1, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)