Clinical trial NCT05064189: Protection of Corneal Epithelium Using Chitosan-N-acetylcysteine Eye Drops During and/or After Cataract Surgery
Official title: Protection of Corneal Epithelium Using Chitosan-N-acetylcysteine Eye Drops During and/or After Cataract Surgery: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eye Diseases
Lead sponsor: Vienna Institute for Research in Ocular Surgery
Sponsor class: OTHER
First posted: 2021-10-01
Enrollment: 45
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference in National Eye Institute Grading Scale (NEI Score)
timeFrame: Day 0
Secondary outcomes:
measure: Difference in NEI Score between all visits post-operatively in the different groups
timeFrame: 7 days +/- 1 day
measure: Difference in break-up time and non-invasive break-up time between the groups at all visits
timeFrame: 7 days +/- 1 day
measure: Difference in NEI Score between the groups at all visits
timeFrame: 7 days +/- 1 day
measure: Subjective complaints using OSDI score
timeFrame: 7 days +/- 1 day
measure: Difference in break-up time and non-invasive break-up time between baseline and 1 week post-operatively in the different groups
timeFrame: 7 days +/- 1 day
measure: Difference in number of MMP-9 positive eyes
timeFrame: 7 days +/- 1 day
measure: Subjective complaints using VAS
timeFrame: 7 days +/- 1 day
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Vienna Institute for Research in Ocular Surgery
Study officials:
affiliation: Vienna Institute for Research in Ocular Surgery
name: Oliver Findl, PrimUnivPrDr
role: PRINCIPAL_INVESTIGATOR
References: