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

Not Applicable

Terminated

• Conditions: Eye Diseases

• Registration Number: NCT05049629
• Lead Sponsor: Vienna Institute for Research in Ocular Surgery

Brief 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).

Detailed 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).

Study Timeline

• Study Start: 2021-05-12
• Primary Completion: 2021-08-31
• Study Completion: 2021-08-31
• Status Verified: 2021-09
• Study First Submitted: 2021-09-01
• Study First Submitted QC: 2021-09-17
• Last Update Submitted: 2021-09-17
• Study First Posted: 2021-09-20
• Last Update Posted: 2021-09-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Difference in spherical and toric IOL power	2 weeks	Difference in spherical and toric IOL power between baseline and the 2 weeks visit
Spherical and toric IOL power	2 weeks	Spherical and toric IOL power selected at the 2 weeks visit

Secondary Outcome Measures

Name	Time	Method
Reproducibility of biometry readings	2 weeks +/- 2 days	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)
Difference between study and control eye	2 weeks +/- 2 days	Difference between study and control eye (baseline and 2 weeks); * BUT (fluorescein and non-invasive BUT); * NEI grading score
Change of dry eye parameters	2 weeks +/- 2 days	Change of dry eye parameters between baseline and 2 weeks; * BUT (fluorescein and non-invasive BUT); * NEI grading score

Trial Locations

Locations (1)

Vienna Institute for Research in Ocular Surgery; 🇦🇹 Vienna, Austria