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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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06658119
Enrollment
90
Registered
2024-10-26
Start date
2024-12-15
Completion date
2026-03-01
Last updated
2025-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Keywords

cataract surgery, intraocular lens, extended depth-of-focus

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.

Interventions

PROCEDUREcataract surgery

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

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Visual acuity1 day, 1 week, 1 month, 3 months postoperativelyVisual 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

MeasureTime frameDescription
Visual quality3 months postoperativelyOPD-scan measurement. Higher-order aberration, tilt and decentration will be recorded.
defocus curve3 months postoperativelyBest distance visual acuity varied from - 5.00 to + 2.00 D in steps of 0.50 D under photopic conditions was recorded.
contrast sensitivity3 months postoperativelyContrast sensitivity will be converted to logarithmic scale before analysis and referred to as log-contrast sensitivity.

Countries

China

Contacts

Primary ContactYueyang Zhong, MD.
yyzbzhong@zju.edu.cn+8618868125901

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026