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NCT Number: NCT06658119

Clinical Evaluation of Extended Depth-of-focus Intraocular Lens in Refractive Cataract Surgery: a Randomized Controlled Trial

The goal of this clinical trial is to compare the clinical outcomes of two extended depth-of-focus intraocular lens after cataract surgery. The randomized controlled trail will enroll 90 participants. The participants will be randomly assigned to implant Tecnis Synergy ZFR00 or Tecnis Symfony ZXR00 intraocular lens. Follow-up visit will be performed till 3 months postoperatively to compare the visual acuity, subjective manifest refraction, and visual quality between groups.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eye Center of the Second Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310058, China

Location status: Recruiting

Location contact

Yueyang Zhong

CONTACT

[email protected]

18868125901

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age-related cataract patients aged between 40 to 80
  • patients with preoperative astigmatism less than 0.75 D, and kappa value less than 0.7 mm
  • patients who plan to receive femtosecond laser-assisted cataract surgery

Exclusion criteria

  • patients with ocular surface abnormalities such as irregular corneal astigmatism, corneal scarring, keratoconus, and pterygium)
  • patients with history of ocular trauma or surgery
  • patients with coexisting ocular disorders such as glaucoma, retinal vascular occlusive disease, retinal detachment, diabetic retinopathy, and any optic nerve-related pathologies
  • patients with concurrent severe systemic diseases
  • patients who lack of cooperation

Treatment and study plan

cataract surgery

Procedure

The participants will receive femtosecond laser-assisted cataract surgery and implant an extended depth-of-focus intraocular lens (Tecnis Synergy ZFR00).

Other names: intraocular lens implantation

Primary outcomes

  1. Visual acuity

    Time frame: 1 day, 1 week, 1 month, 3 months postoperatively

    Visual acuity will be assessed using the Standard Logarithmic Visual Acuity Chart. The results will be recorded in decimal and converted to logMAR and Snellen equivalent.

Secondary outcomes

  1. Visual quality

    Time frame: 3 months postoperatively

    OPD-scan measurement. Higher-order aberration, tilt and decentration will be recorded.

  2. defocus curve

    Time frame: 3 months postoperatively

    Best distance visual acuity varied from - 5.00 to + 2.00 D in steps of 0.50 D under photopic conditions was recorded.

  3. contrast sensitivity

    Time frame: 3 months postoperatively

    Contrast sensitivity will be converted to logarithmic scale before analysis and referred to as log-contrast sensitivity.

Study contacts

Contact information is provided by the study sponsor or research team.

Yueyang Zhong, MD.

CONTACT

[email protected]

+8618868125901

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

Clinical Evaluation of Extended Depth-of-focus Intraocular Lens in Refractive Cataract Surgery

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Oct 26, 2024
Registry last updated
Mar 5, 2025

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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