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

Vienna Institute for Research in Ocular Surgery

Status: Completed

Conditions: Eye Diseases

Treatments: Device: Lacrimera

Study type: Interventional

Funder types: Other

Identifiers

NCT05064189

Lacrimera Staining

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

Group 1

No Intervention group

Description:

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

Group 2

Experimental group

Description:

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

Treatment:

Device: Lacrimera

Group 3

Experimental group

Description:

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

Treatment:

Device: Lacrimera