Effect of Chitosan-N-Acetylcysteine on IOL-power Prior to Cataract Surgery

Eye Diseases Clinical Trial

Official title:

Effect of Chitosan-N-Acetylcysteine (Lacrimera®) on IOL-power Prior to Cataract Surgery: a Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05049629
• Other study ID #: Lacrimera Biometry
• Status: Terminated
• Phase: N/A
• Start date: May 12, 2021
• Est. completion date: August 31, 2021

Study information

• Verified date: September 2021
• Source: Vienna Institute for Research in Ocular Surgery
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Aim of this study is to evaluate the effect of treatment with Lacrimera® on calculated IOL power prior to cataract surgery and on the stability of ocular surface parameters compared to preservative-free, Hyaluronic-acid containing eyedrops (Hylo-Vision® sine).

Description:

The present study seeks to investigate the effect of treatment with Lacrimera® on the calculated IOL power prior to cataract surgery and on the stability of ocular surface parameters compared to preservative-free, Hyaluronic-acid containing eyedrops (Hylo-Vision® sine).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age older than 18 years

• Corneal staining (marked to severe; NEI grading scale >=10)

Exclusion Criteria:

• Usage of eye drops other than lubricants (e.g. antibiotics, steroids, cyclosporin-A)

• Usage of systemic antibiotic therapy 7

• Any pathology of the ocular surface except dry eye disease (e.g. corneal scarring, cornea ectasia)

• Ocular surgery within prior 3 months

• Preceding refractive surgery (e.g. LASIK)

• Ocular injury within prior 3 months

• Ocular herpes of eye or eyelid within prior 3 months

• Active ocular infection

• Active ocular inflammation or history of chronic, recurrent ocular inflammation within prior 3 months

• Eyelid abnormalities that affect lid function

• Ocular surface abnormality that may compromise corneal integrity

• Pregnancy and nursing women (in women of childbearing age a pregnancy test will be performed before inclusion into the study)

Related Conditions & MeSH terms

• Cataract
• Eye Diseases

Intervention

Device:
• 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.
• Hylo-Vision
Preservative-free, Hyaluronic-acid containing eyedrops (Hylo-Vision® sine)

Locations

Country	Name	City	State
Austria	Vienna Institute for Research in Ocular Surgery	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Vienna Institute for Research in Ocular Surgery

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spherical and toric IOL power	Spherical and toric IOL power selected at baseline	1 hour
Primary	Spherical and toric IOL power	Spherical and toric IOL power selected at the 2 weeks visit	2 weeks
Primary	Difference in spherical and toric IOL power	Difference in spherical and toric IOL power between baseline and the 2 weeks visit	2 weeks
Secondary	Reproducibility of biometry readings	Reproducibility of biometry readings at each study visit (Baseline, 1 hour after Baseline, after 1 week, after 2 weeks); Axial length; Keratometry readings (K1, K2)	2 weeks +/- 2 days
Secondary	Change of dry eye parameters	Change of dry eye parameters between baseline and 2 weeks; BUT (fluorescein and non-invasive BUT); NEI grading score	2 weeks +/- 2 days
Secondary	Difference between study and control eye	Difference between study and control eye (baseline and 2 weeks); BUT (fluorescein and non-invasive BUT); NEI grading score	2 weeks +/- 2 days