Performance of a Hydrophilic & a Hydrophobic Intraocular Lens of Similar

Status Withdrawn

Clinical Trial Summary

Comparison of the capsular bag performance of the RayOne Hydrophobic Aspheric with the RayOne Aspheric

Clinical Trial Description

Cataract surgery is nowadays considered a safe surgery with a short rehabilitation time for the patients. Two main problems arising post-surgically are the predictability and stability of the implanted intraocular lens (IOL) in the capsular back and the formation of posterior capsule opacification (PCO). The performance of the IOL in the capsular bag influences the anterior chamber depth (ACD), tilt and decentration of the IOL, as well as formation of PCO. The main source of error for calculation of IOL power is an inaccurate prediction of the post-surgical ACD resulting in short- or farsightedness. Furthermore, capsular fibrosis and phimosis can also lead to tilt and decentration of the intraocular lens. PCO is one of the most frequent long-term complications after cataract surgery, occuring in about 12% after 1 year, in 21% after 3 years, and in 28% after 5 years post-surgically. PCO arises when lens epithelial cells (LECs) migrate and proliferate, growing in between the IOL and the posterior capsule, leading to decreased visual acuity. Material and design of the IOL may have an effect on the formation of PCO. It is suggested that 360° square edge design and hydrophobic material of the IOL may help in the prevention of PCO. Hence, the aim of this study is to evaluate the capsular bag performance of monofocal IOLs with different materials but similar design and their influence on PCO formation. 100 eyes of 50 patients will be included into this study. After randomization one eye is implanted with the hydrophilic IOL, whereas the other eye gets the aspherical IOL. Follow-up visits will be 1 - 2 hours and 1 week after the surgery, as well as 6 months, 12 months, and 24 months post-surgically. During this visit a slit lamp examination, measurement of the intraocular pressure, visual acuity assessment, biometrical measurements of the eye, retroillumination photography and analysis of tilt and decentration of the IOL using the purkinjemeter will be performed. ;

Study Design

Related Conditions & MeSH terms

Cataract

Clinical Trial Details

NCT number	NCT03955796
Study type	Interventional
Source	Vienna Institute for Research in Ocular Surgery
Contact
Status	Withdrawn
Phase	N/A
Start date	May 9, 2019
Completion date	August 3, 2021

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Performance of a Hydrophilic and a Hydrophobic Intraocular Lens of Similar Design

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms