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Active, Not Recruiting

NCT Number: NCT07571694

D615L vs Zeiss 839MP: Visual Quality

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Trifocal IOL

Other

implanted D615L

Primary outcomes

  1. UIVA

    Time frame: From enrollment to the end of treatment at 6 months

    uncorrected-intermediate visual acuity

Sponsors and collaborators

Lead sponsor

Shanghai 10th People's Hospital

Other

Registry information

Official study title

A Comparative Study on Postoperative Visual Quality: New Domestic Trifocal IOL (D615L) Versus Zeiss AT LISA Tri 839MP

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 6, 2026
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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