NCT06892470

Brief Summary

This prospective study aims to compare the visual outcomes following the implantation of two different types of multifocal intraocular lenses (IOLs) in highly myopic patients. The study will evaluate visual quality, refractive outcomes, and patient satisfaction using various visual assessment techniques and subjective satisfaction surveys.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
1mo left

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress95%
Mar 2025May 2026

Study Start

First participant enrolled

March 1, 2025

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 24, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2026

Last Updated

March 24, 2025

Status Verified

March 1, 2025

Enrollment Period

1.2 years

First QC Date

March 21, 2025

Last Update Submit

March 21, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Defocus Curve

    The defocus curve is a tool used to assess visual acuity, particularly widely applied in evaluating the performance of presbyopia-correcting intraocular lenses (IOLs). Its principle involves placing a series of positive and negative lenses of varying diopters in front of the patient's eyes to simulate different distances from near to far, thereby assessing the patient's visual acuity (VA) at each simulated distance.

    Three months after operation

  • Visual Questionnaire

    A visual questionnaire is a tool used to assess patients' visual function and quality of life. It typically includes a series of questions covering various aspects such as visual acuity at different distances (e.g., distance, intermediate, and near vision), dependency on glasses, and the impact of vision on the quality of life. By using a visual questionnaire, one can understand the actual visual experience and satisfaction of patients after the implantation of an intraocular lens.

    Three months after operation

Study Arms (2)

TNF Group:

Implantation of PanOptix trifocal IOL

Other: No intervention

ZFR Group:

Implantation of Tecnis Symfony ZFR00 extended depth of focus IOL (Johnson \& Johnson)

Other: No intervention

Interventions

No intervention

TNF Group:ZFR Group:

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals who undergo micro-incision cataract surgery and implantation of targeted intraocular lenses at the Hangzhou Branch of Wenzhou Medical University Eye Hospital.

You may qualify if:

  • : Patients are older than 18 years
  • : The axial length (AL) measured by IOLMaster 700 is ≥26 mm
  • : No anterior or posterior segment pathology that could potentially compromise visual potential (such as glaucoma, myopic traction maculopathy, corneal leukoma, etc.).
  • : Able to understand, cooperate, and complete all follow - ups

You may not qualify if:

  • : History of amblyopia
  • : Retinal detachment in the same eye or the fellow eye
  • : Presence of multiple peripheral retinal degenerative changes
  • : History of previous ocular surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ophthalmology and Optometry Hos

Hanzhou, Zhejian, China

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice president of Eye Hospital of Wenzhou Medical University

Study Record Dates

First Submitted

March 21, 2025

First Posted

March 24, 2025

Study Start

March 1, 2025

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

May 30, 2026

Last Updated

March 24, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations