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

Not Applicable

Recruiting

• Conditions: Cataract

• Registration Number: NCT06658119
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-23
• Study First Submitted QC: 2024-10-23
• Study First Posted: 2024-10-26
• Study Start: 2024-12-15
• Last Update Submitted: 2025-03-01
• Last Update Posted: 2025-03-05
• Primary Completion: 2025-12-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Visual acuity	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 Outcome Measures

Name	Time	Method
Visual quality	3 months postoperatively	OPD-scan measurement. Higher-order aberration, tilt and decentration will be recorded.
defocus curve	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.
contrast sensitivity	3 months postoperatively	Contrast sensitivity will be converted to logarithmic scale before analysis and referred to as log-contrast sensitivity.

Trial Locations

Locations (1)

Eye Center of the Second Affiliated Hospital of Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China