NCT05255796

Brief Summary

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 cause of poor post-surgery visual quality especially for optical sophisticated IOLs. This negative impact does not affect various types of IOLs equally. Several studies indicated that AL was an independent risk factor of IOL decentration and tilt for emmetropic or moderate myopic eyes. For patients with high myopia, they often have a longer axial length and a larger capsule diameter, which reduces the rotational stability of the IOL and may lead to tilt, decentration and displacement of IOL. Currently, there is no literature guidance to compare the results of cataract surgery combined various types of IOLs implantation in patients with high myopia. The novel anterior segment optical coherence tomography (AS-OCT) device, CASIA2 can 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

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

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

December 13, 2021

Completed
25 days until next milestone

Study Start

First participant enrolled

January 7, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 25, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

February 25, 2022

Status Verified

February 1, 2022

Enrollment Period

7 months

First QC Date

December 13, 2021

Last Update Submit

February 21, 2022

Conditions

Age-related Cataract

Keywords

High MyopiaVarious Types of IOLsThe position of IOL

Outcome Measures

Primary Outcomes (4)

  • The position of IOL

    Evaluation of the position of IOL through tilt, decentration and the process of capsule bending using CASIA2.

    The 1st day after surgery

  • The position of IOL

    Evaluation of the position of IOL through tilt, decentration and the process of capsule bending using CASIA2.

    The 1st week after surgery

  • The position of IOL

    Evaluation of the position of IOL through tilt, decentration and the process of capsule bending using CASIA2.

    The 1st month after surgery

  • The position of IOL

    Evaluation of the position of IOL through tilt, decentration and the process of capsule bending using CASIA2.

    The 3rd month after surgery

Study Arms (2)

one-piece

EXPERIMENTAL

The patients' axial length is over 26 mm and are diagnosed age related cataract or complicated cataract.

Procedure: one-piece

plate-haptic

EXPERIMENTAL

The patients' axial length is over 26 mm and are diagnosed age related cataract or complicated cataract.

Procedure: plate-haptic

Interventions

one-piecePROCEDURE

Patients underwent phacoemulsification cataract surgery with one-piece IOL implantation.

one-piece
plate-hapticPROCEDURE

Patients underwent phacoemulsification cataract surgery with plate-haptic IOL implantation.

plate-haptic

Eligibility Criteria

Age18 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 cataract with axial length over 26mm
  • The patients' age over 18 years old
  • The patients plan to receive cataract surgery in Eye hospital of Wenzhou Medical University
  • The dialated pupils are over 6mm
  • Patients are willing and able to complete the follow-ups

You may not qualify if:

  • Patients with other types 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

Study Sites (1)

Eye Hospital of Wenzhou Medical College

Hangzhou, Zhejiang, 325027, China

RECRUITING

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

December 13, 2021

First Posted

February 25, 2022

Study Start

January 7, 2022

Primary Completion

August 1, 2022

Study Completion

December 1, 2022

Last Updated

February 25, 2022

Record last verified: 2022-02

Locations

CN(1)