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

Eye Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05064189
• Other study ID #: Lacrimera Staining
• Status: Completed
• Phase: N/A
• Start date: April 14, 2021
• Est. completion date: September 10, 2021

Study information

• Verified date: September 2021
• Source: Vienna Institute for Research in Ocular Surgery
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 10, 2021
• Est. primary completion date: September 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Capsule Opacification
• Cataract
• Eye Diseases

Intervention

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.

Locations

Country	Name	City	State
Austria	Vienna Institute for Research in Ocular Surgery	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Vienna Institute for Research in Ocular Surgery

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Difference in NEI Score between the groups at all visits	Difference in NEI Score between the groups at all visits	7 days +/- 1 day
Secondary	Subjective complaints using OSDI score	Subjective complaints in the 3 groups using OSDI score	7 days +/- 1 day
Secondary	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
Secondary	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
Secondary	Subjective complaints using VAS	Subjective complaints in the 3 groups using VAS	7 days +/- 1 day