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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cataract
• Intervention / Treatment: Procedure: cataract surgery; Procedure: cataract surgery

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yueyang Zhong, MD.; Phone Number: +8618868125901; Email: yyzbzhong@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310058
      • Recruiting
      • Eye Center of the Second Affiliated Hospital of Zhejiang University
      • Contact: Yueyang Zhong; Phone Number: 18868125901; Email: annie.zhongyy@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tecnis Synergy ZFR00 IOL; Tecnis Synergy ZFR00 IOL will be implanted in the patient's eye during cataract surgery.	Procedure: cataract surgery; 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; Procedure: cataract surgery; The participants will receive femtosecond laser-assisted cataract surgery and implant an extended depth-of-focus intraocular lens (Tecnis Symfony ZXR00).; Other Names: intraocular lens implantation
Placebo Comparator: Tecnis Symfony ZXR00 IOL; Tecnis Symfony ZXR00 IOL will be implanted in the patient's eye during cataract surgery.	Procedure: cataract surgery; 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; Procedure: cataract surgery; The participants will receive femtosecond laser-assisted cataract surgery and implant an extended depth-of-focus intraocular lens (Tecnis Symfony ZXR00).; Other Names: intraocular lens implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual acuity	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.	1 day, 1 week, 1 month, 3 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual quality	OPD-scan measurement. Higher-order aberration, tilt and decentration will be recorded.	3 months postoperatively
defocus curve	Best distance visual acuity varied from - 5.00 to + 2.00 D in steps of 0.50 D under photopic conditions was recorded.	3 months postoperatively
contrast sensitivity	Contrast sensitivity will be converted to logarithmic scale before analysis and referred to as log-contrast sensitivity.	3 months postoperatively

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: October 23, 2024
• First Submitted That Met QC Criteria: October 23, 2024
• First Posted (Actual): October 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 1, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: intraocular lens; cataract surgery; extended depth-of-focus
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: 20241068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not a plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No