Clinical trial NCT05049629: 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
Overall status: TERMINATED
Phase: NA
Conditions: Eye Diseases
Lead sponsor: Vienna Institute for Research in Ocular Surgery
Sponsor class: OTHER
First posted: 2021-09-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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).

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)

Primary outcomes:
measure: Spherical and toric IOL power
timeFrame: 1 hour
measure: Spherical and toric IOL power
timeFrame: 2 weeks
measure: Difference in spherical and toric IOL power
timeFrame: 2 weeks
Secondary outcomes:
measure: Reproducibility of biometry readings
timeFrame: 2 weeks +/- 2 days
measure: Change of dry eye parameters
timeFrame: 2 weeks +/- 2 days
measure: Difference between study and control eye
timeFrame: 2 weeks +/- 2 days
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Vienna Institute for Research in Ocular Surgery
Study officials:
affiliation: Vienna Institute for Research in Ocular Surgery
name: Oliver Findl, PrimUnivPrDr
role: PRINCIPAL_INVESTIGATOR
References: