Effect of Chitosan-N-Acetylcysteine on IOL-power Prior to Cataract Surgery
- Conditions
- Eye Diseases
- Interventions
- Device: Hylo-VisionDevice: Lacrimera
- 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).
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 30
- Age older than 18 years
- Corneal staining (marked to severe; NEI grading scale >=10)
- 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
- Arm && Interventions
Group Intervention Description Eye 2 Hylo-Vision 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. Eye 1 Lacrimera 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 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 scoreChange 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