Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05263518 |
| Other study ID # |
TORIC stability |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2022 |
| Est. completion date |
December 1, 2022 |
Study information
| Verified date |
April 2022 |
| Source |
Wenzhou Medical University |
| Contact |
Pingjun Chang |
| Phone |
18868410303 |
| Email |
364669877[@]qq.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Corneal astigmatism is refractive error that impairs uncorrected visual acuity. When patients
undergo cataract surgery, implantation of toric IOL is deemed the most effective choice for
correcting corneal astigmatism and reducing postoperative spectacle dependence. The
IOL-capsular complex is formed after cataract surgery and intraocular lens (IOL)
implantation. Early postoperative mechanical wrapping of the anterior and posterior capsules
plays a significant role in preventing IOL decentration and tilt, as well as formation of the
IOL-capsular complex which reduces the incidence of posterior cataract opacity. IOL
decentration ≥ 0.4 mm or/and IOL tilt ≥7degree were considered clinically significant because
of poor post-surgery visual quality especially for optical sophisticated IOLs such as toric
IOLs. IOL instability could decrease the curative effect of toric IOL. There are numerous
types of toric IOLs; however, AcrySof IQ and TECNIS toric IOL are most frequently used in the
Ophthalmology Hospital of Wenzhou Medical University. AcrySof IQ IOL has some differences
compared with TECNIS toric IOL. IQ has a modified L haptic design while TECNIS® toric IOL has
a modified C haptic design. AcrySof IQ IOL has a discontinuous 360˚ posterior square edge
while TECNIS toric IOL has a continuous 360˚ posterior square edge. The AcrySof IQ IOL
cylinder power models include 1.00, 1.50, 2.25, 3.00, 3.75, 4.50, 5.25 and 6.00 D. The Tecnis
IOL cylinder power models include 1.00, 1.50, 2.25, 3.00 and 4.00 D. Previous study pointed
that patients with cataracts with corneal astigmatism achieved comparable improvement in
visual acuity, astigmatism correction, CS（sensitive contrast）, rotational stability and
satisfaction, following AcrySof and TECNIS toric IOL implantation. However，some other studies
found that the Acrysof toric IOL showed significantly greater rotational stability than the
Tecnis toric IOL and the rate of surgical IOL repositioning was higher in eyes implanted with
TECNIS than with AcrySof toric IOLs for astigmatic correction. Currently, there is no
literature guidance to compare the results of cataract surgery combined various types of
toric IOLs implantation in patients using CASIA2. The novel anterior segment optical
coherence tomography (AS-OCT) device, CASIA2 can accurately evaluate the IOL capsule bending
and the lens position after cataract surgery. Also, CASIA2 can be used to documented the
dynamic changes of IOL-capsular complex after surgery.
Description:
Corneal astigmatism is refractive error that impairs uncorrected visual acuity. When patients
undergo cataract surgery, implantation of toric IOL is deemed the most effective choice for
correcting corneal astigmatism and reducing postoperative spectacle dependence. The
IOL-capsular complex is formed after cataract surgery and intraocular lens (IOL)
implantation. Early postoperative mechanical wrapping of the anterior and posterior capsules
plays a significant role in preventing IOL decentration and tilt, as well as formation of the
IOL-capsular complex which reduces the incidence of posterior cataract opacity.
Although up to 2-3 degree tilt and a 0.2-0.3 mm decentration are common and clinically
unnoticed for any design of IOL, larger extent of tilt and decentration has a negative impact
on the optical performance. IOL decentration ≥ 0.4 mm or/and IOL tilt ≥7degree were
considered clinically significant because of poor post-surgery visual quality especially for
optical sophisticated IOLs such as toric IOLs. IOL instability could decrease the curative
effect of toric IOL. There are numerous types of toric IOLs; however, AcrySof IQ and TECNIS
toric IOL are most frequently used in the Ophthalmology Hospital of Wenzhou Medical
University. AcrySof IQ IOL has some differences compared with TECNIS toric IOL. IQ has a
modified L haptic design while TECNIS® toric IOL has a modified C haptic design. AcrySof IQ
IOL has a discontinuous 360˚ posterior square edge while TECNIS toric IOL has a continuous
360˚ posterior square edge. The AcrySof IQ IOL cylinder power models include 1.00, 1.50,
2.25, 3.00, 3.75, 4.50, 5.25 and 6.00 D. The Tecnis IOL cylinder power models include 1.00,
1.50, 2.25, 3.00 and 4.00 D. Previous study pointed that patients with cataracts with corneal
astigmatism achieved comparable improvement in visual acuity, astigmatism correction,
CS（sensitive contrast）, rotational stability and satisfaction, following AcrySof and TECNIS
toric IOL implantation. However，some other studies found that the Acrysof toric IOL showed
significantly greater rotational stability than the Tecnis toric IOL and the rate of surgical
IOL repositioning was higher in eyes implanted with TECNIS than with AcrySof toric IOLs for
astigmatic correction. Currently, there is no literature guidance to compare the results of
cataract surgery combined various types of toric IOLs implantation in patients using CASIA2.
The novel anterior segment optical coherence tomography (AS-OCT) device, CASIA2 can
accurately evaluate the IOL capsule bending and the lens position after cataract surgery.
Also, CASIA2 can be used to documented the dynamic changes of IOL-capsular complex after
surgery.
