Clinical Evaluation of Extended Depth-of-focus Intraocular Lens in Refractive Cataract Surgery: a Randomized Controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: cataract surgery, cataract surgery.
- Who it may be relevant to
- Registry conditions: Cataract. Basic parameters: 40 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Evaluation of Extended Depth-of-focus Intraocular Lens in Refractive Cataract Surgery
Overview
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
- Procedure cataract surgery
The participants will receive femtosecond laser-assisted cataract surgery and implant an extended depth-of-focus intraocular lens (Tecnis Synergy ZFR00). - Procedure cataract surgery
The participants will receive femtosecond laser-assisted cataract surgery and implant an extended depth-of-focus intraocular lens (Tecnis Symfony ZXR00).
Primary outcome measures
- Visual acuity [Time frame: 1 day, 1 week, 1 month, 3 months postoperatively]
Secondary outcome measures (3)
- Visual quality [Time frame: 3 months postoperatively]
- defocus curve [Time frame: 3 months postoperatively]
- contrast sensitivity [Time frame: 3 months postoperatively]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Eye Center of the Second Affiliated Hospital of Zhejiang University — Hangzhou
Identifiers
NCT: NCT06658119 · 20241068