Protection of Corneal Epithelium Using Chitosan-N-acetylcysteine Eye Drops During and/or After Cataract Surgery
NCT ID: NCT05064189
Last Updated: 2021-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
45 participants
INTERVENTIONAL
2021-04-14
2021-09-10
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Group 1
15 patients will be included in group 1 (no additional treatment)
No interventions assigned to this group
Group 2
15 patients will be in group 2 (treatment directly after cataract surgery in the surgical theatre)
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.
Group 3
15 patients will receive treatment after local anaesthesia (pre-operatively) and directly after cataract surgery (group 3)
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
22 Years
ALL
No
Sponsors
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Vienna Institute for Research in Ocular Surgery
OTHER
Responsible Party
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Prim. Prof. Dr. Oliver Findl, MBA
Principal Investigator
Principal Investigators
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Oliver Findl, PrimUnivPrDr
Role: PRINCIPAL_INVESTIGATOR
Vienna Institute for Research in Ocular Surgery
Locations
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Vienna Institute for Research in Ocular Surgery
Vienna, , Austria
Countries
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Other Identifiers
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Lacrimera Staining
Identifier Type: -
Identifier Source: org_study_id
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