NCT07571694

Brief Summary

The goal of this prospective cohort study is to compare visual quality after cataract surgery in patients implanted with a new domestic trifocal intraocular lens (D615L) versus the Zeiss AT LISA tri 839MP. The main question it aims to answer is: Is the uncorrected distance, intermediate, and near visual acuity achieved with D615L non-inferior or superior to that achieved with the Zeiss 839MP? Participants diagnosed with age-related cataract will undergo phacoemulsification and receive one of the two intraocular lenses. They will attend follow-up visits where uncorrected visual acuity, defocus curves, and the VF-14 questionnaire will be assessed over a follow-up period of at least 6 months.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
8mo left

Started Apr 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

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Study Timeline

Key milestones and dates

Study Progress63%
Apr 2025Dec 2026

Study Start

First participant enrolled

April 1, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 27, 2026

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 6, 2026

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

May 6, 2026

Status Verified

March 1, 2026

Enrollment Period

1.1 years

First QC Date

April 27, 2026

Last Update Submit

May 2, 2026

Conditions

Cataract

Keywords

Cataract

Outcome Measures

Primary Outcomes (1)

  • UIVA

    uncorrected-intermediate visual acuity

    From enrollment to the end of treatment at 6 months

Study Arms (2)

D615L

implanted D615L IOL

Other: Trifocal IOL

839MP

implanted 839MP IOL

Interventions

Trifocal IOLOTHER

implanted D615L

D615L

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with age-related cataract

You may qualify if:

  • diagnosed age-related cataract;
  • preoperative corneal astigmatism \<1.0 D;
  • endothelial cell count \>2000/mm²;
  • signed informed consent and ability to complete 6-month follow-up

You may not qualify if:

  • prior corneal refractive, glaucoma or vitreoretinal surgery;
  • intraoperative posterior capsule rupture, zonular dehiscence or vitreous loss;
  • corneal pathology, macular edema or optic neuropathy affecting visual assessment;
  • active ocular inflammation, glaucoma, maculopathy or diabetic retinopathy;
  • uncontrolled systemic disease such as diabetes or autoimmune disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident physician of Ophthalmology

Study Record Dates

First Submitted

April 27, 2026

First Posted

May 6, 2026

Study Start

April 1, 2025

Primary Completion

April 28, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

May 6, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)