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

Vienna Institute for Research in Ocular Surgery

Status: Terminated

Conditions: Eye Diseases

Treatments: Device: Hylo-Vision; Device: Lacrimera

Study type: Interventional

Funder types: Other

Identifiers

NCT05049629

Lacrimera Biometry

Details and patient eligibility

About

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).

Full 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).

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Eye 1

Experimental group

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.

Treatment:

Device: Lacrimera

Eye 2

Active Comparator group

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.

Treatment:

Device: Hylo-Vision