NCT04443101

Brief Summary

Cataract patients were implanted with different types of intraocular lenses for grouping. SSOCT scanning was used to measure ELP and optometry.

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
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

January 1, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 17, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 23, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2022

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2023

Completed
Last Updated

March 7, 2023

Status Verified

March 1, 2023

Enrollment Period

3.4 years

First QC Date

June 17, 2020

Last Update Submit

March 5, 2023

Conditions

Age-related Cataract

Outcome Measures

Primary Outcomes (1)

  • effective lens position

    Changes of effective lens position at different time points after cataract surgery

    up to 3 months after cataract surgery

Study Arms (3)

Group（SN6CWS）

Group（SN6CWS）：Implant SN6CWS intraocular lens

Other: different types of intracular lens

Group（MI60）

Group（MI60）：Implant MI60 intraocular lens

Other: different types of intracular lens

Group（Aspira-aA）

Group（Aspira-aA）：Implant Aspira-aA intraocular lens

Other: different types of intracular lens

Interventions

different types of intracular lensOTHER

different types of intracular lens

Group（Aspira-aA）Group（MI60）Group（SN6CWS）

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

* Diagnosed as cataract in our hospital; * Implanted intraocular lens: SN6CWS, Aspira-aA, MI60; * Cataract phacoemulsification and intraocular lens implantation.

You may qualify if:

  • a.Diagnosed as cataract;
  • b.Implanted intraocular lens: SN6CWS, Aspira-aA, MI60;
  • c.Cataract phacoemulsification and intraocular lens implantation.

You may not qualify if:

  • a.Combined with corneal opacity, glaucoma, uveitis, retinal detachment and other eye diseases;
  • b.A history of intraocular surgery or trauma other than cataract surgery;
  • c.Intraoperative complications such as tearing of the capsule and IOL failure to implant;
  • d.Endophthalmitis, corneal endothelial decompensation and other postoperative complications;
  • e.Those with incomplete data collected during the follow-up period of postoperative patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ophthalmology and Optometry Hospital

Wenzhou, Zhejiang, 325027, China

RECRUITING

Wenzhou Medical University

Wenzhou, Zhejiang, 325027, China

RECRUITING

Central Study Contacts

xixia ding, Phd

CONTACT

+8613780148109dingxixiaxc@163.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 17, 2020

First Posted

June 23, 2020

Study Start

January 1, 2019

Primary Completion

May 30, 2022

Study Completion

March 30, 2023

Last Updated

March 7, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)