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

Sponsor

Vienna Institute for Research in Ocular Surgery (Other)

Overall Status

Terminated

CT.gov ID

NCT05049629

Collaborator

(none)

Enrollment

Location

Arms

3.6

Actual Duration (Months)

8.2

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Eye Diseases	Device: Lacrimera Device: Hylo-Vision	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

After enrolment into the study three study visits will be scheduled. The selection of the study eye will be randomized using www.randomizer.org. The contralateral eye serves as the control eye. After the baseline examination and the follow-up examination one hour later, patients will be released with a prescription of one drop of Lacrimera® into the study eye per day in the evening and with one drop of single-use preservative-free hyaluronic acid containing eye drops (Hylo-Vision® sine) into the control eye three times a day for 14 consecutive days.After enrolment into the study three study visits will be scheduled. The selection of the study eye will be randomized using www.randomizer.org. The contralateral eye serves as the control eye. After the baseline examination and the follow-up examination one hour later, patients will be released with a prescription of one drop of Lacrimera® into the study eye per day in the evening and with one drop of single-use preservative-free hyaluronic acid containing eye drops (Hylo-Vision® sine) into the control eye three times a day for 14 consecutive days.

Masking:

None (Open Label)

Masking Description:

All study-related measurements will be performed by a masked observer.

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

May 12, 2021

Actual Primary Completion Date :

Aug 31, 2021

Actual Study Completion Date :

Aug 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Eye 1 The contralateral eye serves as the control eye. After the baseline examination and the follow-up examination one hour later, patients will be released with a prescription of one drop of Lacrimera® into the study eye per day in the evening and with one drop of single-use preservative-free hyaluronic acid containing eye drops (Hylo-Vision® sine) into the control eye three times a day for 14 consecutive days.	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.
Active Comparator: Eye 2 The contralateral eye serves as the control eye. After the baseline examination and the follow-up examination one hour later, patients will be released with a prescription of one drop of Lacrimera® into the study eye per day in the evening and with one drop of single-use preservative-free hyaluronic acid containing eye drops (Hylo-Vision® sine) into the control eye three times a day for 14 consecutive days.	Device: Hylo-Vision Preservative-free, Hyaluronic-acid containing eyedrops (Hylo-Vision® sine)

Arm

Intervention/Treatment

Experimental: Eye 1

The contralateral eye serves as the control eye. After the baseline examination and the follow-up examination one hour later, patients will be released with a prescription of one drop of Lacrimera® into the study eye per day in the evening and with one drop of single-use preservative-free hyaluronic acid containing eye drops (Hylo-Vision® sine) into the control eye three times a day for 14 consecutive days.

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.

Active Comparator: Eye 2

Device: Hylo-Vision

Preservative-free, Hyaluronic-acid containing eyedrops (Hylo-Vision® sine)

Outcome Measures

Primary Outcome Measures

Spherical and toric IOL power [1 hour]
Spherical and toric IOL power selected at baseline
Spherical and toric IOL power [2 weeks]
Spherical and toric IOL power selected at the 2 weeks visit
Difference in spherical and toric IOL power [2 weeks]
Difference in spherical and toric IOL power between baseline and the 2 weeks visit

Secondary Outcome Measures

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)
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vienna Institute for Research in Ocular Surgery	Vienna		Austria	1140

Sponsors and Collaborators

Vienna Institute for Research in Ocular Surgery

Investigators

Principal Investigator: Oliver Findl, PrimUnivPrDr, Vienna Institute for Research in Ocular Surgery

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Prim. Prof. Dr. Oliver Findl, MBA, Principal Investigator, Vienna Institute for Research in Ocular Surgery

ClinicalTrials.gov Identifier:

NCT05049629

Other Study ID Numbers:

Lacrimera Biometry

First Posted:

Sep 20, 2021

Last Update Posted:

Sep 20, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cataract

Eye Diseases

Study Results

No Results Posted as of Sep 20, 2021