NCT05263518

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

April 19, 2022

Status Verified

April 1, 2022

Enrollment Period

4 months

First QC Date

February 21, 2022

Last Update Submit

April 17, 2022

Conditions

Corneal AstigmatismCataract

Keywords

Various Types of toric IOLs

Outcome Measures

Primary Outcomes (4)

  • The position of IOL

    Evaluation of the position of IOL through tilt, decentration，rotation and the process of capsule bending using CAISA2（The novel anterior segment optical coherence tomography (AS-OCT) device）

    The 1st day after surgery

  • The position of IOL

    Evaluation of the position of IOL through tilt, decentration，rotation and the process of capsule bending using CAISA2（The novel anterior segment optical coherence tomography (AS-OCT) device）

    The 1st week after surgery

  • The position of IOL

    Evaluation of the position of IOL through tilt, decentration，rotation and the process of capsule bending using CAISA2（The novel anterior segment optical coherence tomography (AS-OCT) device）

    The 1st month after surgery

  • The position of IOL

    Evaluation of the position of IOL through tilt, decentration，rotation and the process of capsule bending using CAISA2（The novel anterior segment optical coherence tomography (AS-OCT) device）

    The 3rd month after surgery

Study Arms (2)

AcrySof IQ toric IOL

EXPERIMENTAL

patients who had cataract surgery with AcrySof IQ toric IOL implantation. The patients diagnosed age related cataract The patients' ages are over 50.

Procedure: Cataract surgery with AcrySof IQ IOL implantation.

TECNIS toric IOL

EXPERIMENTAL

patients who had cataract surgery with TECNIS toric IOL implantation. The patients are diagnosed age related cataract. The patients' ages are over 50.

Procedure: Cataract surgery with TECNIS toric IOL implantation.

Interventions

Cataract surgery with AcrySof IQ IOL implantation.PROCEDURE

Patients in this study will receive cataract surgery with AcrySof IQ IOL implantation.

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

Patients in this study will receive cataract surgery with TECNIS toric IOL implantation.

TECNIS toric IOL

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patients are diagnosed age related cataract or complicated with corneal astigmatism
  • The patients' age over 50 years old
  • The patients plan to receive cataract surgery in Eye hospital of Wenzhou Medical University
  • The dilated pupils are over 7mm
  • Patients are willing and able to complete the follow-ups.

You may not qualify if:

  • Patients with other type of cataract
  • Patients have complications in the surgery and after surgery
  • Patients have other severe diseases of eyes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Wang Y, Lou X, Qian S, Li Y, Wu X, Li S, Wang Y, Zhao Y, Chang P. Comparison of the effect of capsular bend on the rotational stability between 2 toric intraocular lenses. J Cataract Refract Surg. 2024 Mar 1;50(3):283-288. doi: 10.1097/j.jcrs.0000000000001373.

    PMID: 38085243DERIVED

MeSH Terms

Conditions

AstigmatismCataract

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Refractive ErrorsEye DiseasesLens Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Yune Zhao

    Ophthalmology and Optometry Hospital

    STUDY DIRECTOR

Central Study Contacts

Pingjun Chang

CONTACT

18868410303364669877@qq.com

Yune Zhao, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice president of Eye Hospital of Wenzhou Medical University

Study Record Dates

First Submitted

February 21, 2022

First Posted

March 2, 2022

Study Start

May 1, 2022

Primary Completion

September 1, 2022

Study Completion

December 1, 2022

Last Updated

April 19, 2022

Record last verified: 2022-04