NCT06092164

Brief Summary

This is a prospective, multi-center, randomized comparative study. The purpose of the study is to evaluate and compare the objective and subjective visual outcomes of different types of functional intraocular lenses (IOLs) in patients.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
20,000

participants targeted

Target at P75+ for all trials

Timeline
68mo left

Started Dec 2023

Longer than P75 for all trials

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress30%
Dec 2023Dec 2031

First Submitted

Initial submission to the registry

October 15, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2029

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2031

Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

6.1 years

First QC Date

October 15, 2023

Last Update Submit

October 19, 2023

Conditions

CataractVisual Quality

Outcome Measures

Primary Outcomes (4)

  • uncorrected distance visual acuity (UDVA)

    uncorrected visual acuity at 5 m

    one year

  • best corrected distance visual acuity (BCVA)

    corrected visual acuity at 5 m

    one year

  • uncorrected near visual acuity (UNVA)

    uncorrected visual acuity at 40 cm

    one year

  • uncorrected intermediate visual acuity (UIVA)

    uncorrected visual acuity at 60 cm

    one year

Secondary Outcomes (8)

  • HOAs

    three months

  • Strehl Ratio

    three months

  • objective visual quality

    three months

  • contrast sensitivity

    three months

  • visual functions

    three months

  • +3 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Catarct

You may qualify if:

  • cataract
  • age \> 18 years

You may not qualify if:

  • amblyopia; previous ocular surgery;
  • ocular pathologies such as diabetic retinopathy, macular degeneration, glaucoma with field defects;
  • requirements for further ocular surgery (other than Nd:YAG capsulotomy) or retinal laser treatments during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Jin Yang

    Department of Ophthalmology, Eye and Ear, Nose, and Throat Hospital, Fudan University

    STUDY DIRECTOR

Central Study Contacts

Jin Yang

CONTACT

+8613671632525jin_er76@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 15, 2023

First Posted

October 23, 2023

Study Start

December 1, 2023

Primary Completion (Estimated)

December 30, 2029

Study Completion (Estimated)

December 30, 2031

Last Updated

October 23, 2023

Record last verified: 2023-10