NCT05263518

Influence of Different Toric Intraocular Lenses on IOL-capsular Complex

Status unknown NA Last updated 19 April 2022

What this trial tests

NA trial testing Cataract surgery with AcrySof IQ IOL implantation. in Corneal Astigmatism in 100 participants. Status unknown.

Timeline

1 May 2022

Primary endpoint
1 September 2022

1 December 2022

Quick facts

Lead sponsor	Wenzhou Medical University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	100
Start date	1 May 2022
Primary completion	1 September 2022
Estimated completion	1 December 2022

Drugs / interventions tested

• Cataract surgery with AcrySof IQ IOL implantation.
• Cataract surgery with TECNIS toric IOL implantation.

Conditions studied

• Corneal Astigmatism — all drugs for Corneal Astigmatism →
• Cataract — all drugs for Cataract →

Sponsor

Wenzhou Medical University

Who can join

Adults 50 to 90, any sex, with Corneal Astigmatism or Cataract. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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. 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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Comparison of the effect of capsular bend on the rotational stability between 2 toric intraocular lenses.
   Wang Y, Lou X, Qian S, Li Y, et al · · 2024 · cited 4× · PMID 38085243 · DOI 10.1097/j.jcrs.0000000000001373