Clinical Trial Details
— Status: Withdrawn
Administrative data
NCT number |
NCT03955796 |
Other study ID # |
Ray hydrophobic |
Secondary ID |
|
Status |
Withdrawn |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
May 9, 2019 |
Est. completion date |
August 3, 2021 |
Study information
Verified date |
August 2021 |
Source |
Vienna Institute for Research in Ocular Surgery |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Comparison of the capsular bag performance of the RayOne Hydrophobic Aspheric with the RayOne
Aspheric
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.