Vienna Institute for Research in Ocular Surgery
Vienna, 1140, Austria
NCT Number: NCT05064189
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.
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Notify Me22 year and older
All sexes
Interventional
Not applicable
Vienna, 1140, Austria
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Day 0
Difference in National Eye Institute Grading Scale (NEI Score) between baseline and 1 hour post cataract surgery
Time frame: 7 days +/- 1 day
Difference in NEI Score between all visits post-operatively in the different groups
Time frame: 7 days +/- 1 day
Difference in break-up time and non-invasive break-up time between the groups at all visits
Time frame: 7 days +/- 1 day
Difference in NEI Score between the groups at all visits
Time frame: 7 days +/- 1 day
Subjective complaints in the 3 groups using OSDI score
Time frame: 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
Time frame: 7 days +/- 1 day
Difference in number of MMP-9 positive eyes before surgery and 1 week after surgery in the different groups
Time frame: 7 days +/- 1 day
Subjective complaints in the 3 groups using VAS
Vienna Institute for Research in Ocular Surgery
Other
Protection of Corneal Epithelium Using Chitosan-N-acetylcysteine Eye Drops During and/or After Cataract Surgery: a Pilot Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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