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

Not Applicable

Completed

• Conditions: Eye Diseases
• Interventions: Device: Lacrimera

• Registration Number: NCT05064189
• Lead Sponsor: Vienna Institute for Research in Ocular Surgery

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.

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 Timeline

• Study Start: 2021-04-14
• Study First Submitted: 2021-08-31
• Status Verified: 2021-09
• Primary Completion: 2021-09-10
• Study Completion: 2021-09-10
• Study First Submitted QC: 2021-09-21
• Last Update Submitted: 2021-09-21
• Study First Posted: 2021-10-01
• Last Update Posted: 2021-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 3	Lacrimera	15 patients will receive treatment after local anaesthesia (pre-operatively) and directly after cataract surgery (group 3)
Group 2	Lacrimera	15 patients will be in group 2 (treatment directly after cataract surgery in the surgical theatre)

Primary Outcome Measures

Name	Time	Method
Difference in National Eye Institute Grading Scale (NEI Score)	Day 0	Difference in National Eye Institute Grading Scale (NEI Score) between baseline and 1 hour post cataract surgery

Secondary Outcome Measures

Name	Time	Method
Subjective complaints using OSDI score	7 days +/- 1 day	Subjective complaints in the 3 groups using OSDI score
Difference in break-up time and non-invasive break-up time between the groups at all visits	7 days +/- 1 day	Difference in break-up time and non-invasive break-up time between the groups at all visits
Difference in number of MMP-9 positive eyes	7 days +/- 1 day	Difference in number of MMP-9 positive eyes before surgery and 1 week after surgery in the different groups
Subjective complaints using VAS	7 days +/- 1 day	Subjective complaints in the 3 groups using VAS
Difference in NEI Score 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 all visits post-operatively in the different groups	7 days +/- 1 day	Difference in NEI Score between all visits 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 break-up time and non-invasive break-up time between baseline and 1 week post-operatively in the different groups

Trial Locations

Locations (1)

Vienna Institute for Research in Ocular Surgery; 🇦🇹 Vienna, Austria