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

NCT05049629 | Terminated

• 1 other identifier: Lacrimera Biometry
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Eye Diseases

Outcome Measures

Primary Outcomes (3)

• Spherical and toric IOL power

  Spherical and toric IOL power selected at baseline

  1 hour

• Spherical and toric IOL power

  Spherical and toric IOL power selected at the 2 weeks visit

  2 weeks

• Difference in spherical and toric IOL power

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

  2 weeks

Secondary Outcomes (3)

• Reproducibility of biometry readings

  2 weeks +/- 2 days

• Change of dry eye parameters

  2 weeks +/- 2 days

• Difference between study and control eye

  2 weeks +/- 2 days

Study Arms (2)

Eye 1

EXPERIMENTAL

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

Eye 2

ACTIVE COMPARATOR

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

Interventions

Lacrimera DEVICE

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.

Eye 1

Hylo-Vision DEVICE

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

Eye 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age older than 18 years
• Corneal staining (marked to severe; NEI grading scale \>=10)

You may not qualify if:

• 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

Sponsors & Collaborators

• Vienna Institute for Research in Ocular Surgery: lead

Study Sites (1)

Vienna Institute for Research in Ocular Surgery

Vienna, 1140, Austria

Location

MeSH Terms

Conditions

Eye Diseases

Study Officials

• Oliver Findl, PrimUnivPrDr

  Vienna Institute for Research in Ocular Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: All study-related measurements will be performed by a masked observer.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 1, 2021
• First Posted: September 20, 2021
• Study Start: May 12, 2021
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: September 20, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)