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

Primary Purpose

Eye Diseases

Status
Terminated
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Lacrimera
Hylo-Vision
Sponsored by
Vienna Institute for Research in Ocular Surgery
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Eye Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Vienna Institute for Research in Ocular Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Eye 1

Eye 2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
Change of dry eye parameters
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
Difference between study and control eye (baseline and 2 weeks) BUT (fluorescein and non-invasive BUT) NEI grading score

Full Information

First Posted
September 1, 2021
Last Updated
September 17, 2021
Sponsor
Vienna Institute for Research in Ocular Surgery
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1. Study Identification

Unique Protocol Identification Number
NCT05049629
Brief Title
Effect of Chitosan-N-Acetylcysteine on IOL-power Prior to Cataract Surgery
Official Title
Effect of Chitosan-N-Acetylcysteine (Lacrimera®) on IOL-power Prior to Cataract Surgery: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
Medical device expired
Study Start Date
May 12, 2021 (Actual)
Primary Completion Date
August 31, 2021 (Actual)
Study Completion Date
August 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vienna Institute for Research in Ocular Surgery

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eye Diseases

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Masking Description
All study-related measurements will be performed by a masked observer.
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Eye 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Eye 2
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Lacrimera
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Hylo-Vision
Intervention Description
Preservative-free, Hyaluronic-acid containing eyedrops (Hylo-Vision® sine)
Primary Outcome Measure Information:
Title
Spherical and toric IOL power
Description
Spherical and toric IOL power selected at baseline
Time Frame
1 hour
Title
Spherical and toric IOL power
Description
Spherical and toric IOL power selected at the 2 weeks visit
Time Frame
2 weeks
Title
Difference in spherical and toric IOL power
Description
Difference in spherical and toric IOL power between baseline and the 2 weeks visit
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Reproducibility of biometry readings
Description
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)
Time Frame
2 weeks +/- 2 days
Title
Change of dry eye parameters
Description
Change of dry eye parameters between baseline and 2 weeks BUT (fluorescein and non-invasive BUT) NEI grading score
Time Frame
2 weeks +/- 2 days
Title
Difference between study and control eye
Description
Difference between study and control eye (baseline and 2 weeks) BUT (fluorescein and non-invasive BUT) NEI grading score
Time Frame
2 weeks +/- 2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oliver Findl, PrimUnivPrDr
Organizational Affiliation
Vienna Institute for Research in Ocular Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vienna Institute for Research in Ocular Surgery
City
Vienna
ZIP/Postal Code
1140
Country
Austria

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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