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Clinical Study on Hybrid Implantation of Extended Depth of Focus and Toric Multifocal Intraocular Lenses in Bilateral Eyes

Clinical Study on Hybrid Implantation of Extended Depth of Focus and Toric Multifocal Intraocular Lenses in Bilateral Eyes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600123286
Enrollment
Unknown
Registered
2026-04-23
Start date
2026-04-24
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

cataract

Interventions

Control 1 Group:Bilateral implantation of ZXR00 intraocular lens (IOL)
Control 2 Group:Bilateral implantation of ZMT intraocular lens (IOL)
Hybrid Group:Hybrid bilateral implantation of ZXR00 and ZMT intraocular lenses (IOLs)

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients aged 50 or older, diagnosed with bilateral age-related cataracts or bilateral senile cataracts, have surgical indications; 2. Have a postoperative desire to be free from glasses and meet the implantation indications for presbyopia-correcting IOLs; 3. During preoperative communication, patients understand the impact of astigmatism on the visual quality of presbyopia correction, are willing to choose the same or different types of presbyopia-correcting IOLs for both eyes, and accept the possibility of incomplete freedom from glasses or the need for IOL replacement surgery due to severe visual disturbances; 4. The IOLs implanted in both eyes are all from J&J, including mixed implantation of bilateral ZXR00 and ZMT, bilateral ZXR00 implantation, or bilateral ZMT implantation; 5. Postoperative follow-up time is 3 months or more, with available follow-up data beyond 3 months.

Exclusion criteria

Exclusion criteria: 1. Patients with severe or progressively worsening eye diseases (such as glaucoma, macular degeneration, diabetic retinopathy, optic neuropathy, etc.); 2. Patients with organic eye lesions such as extremely high myopia with microphthalmia or pathological fundus changes, significantly abnormal pupils, severe corneal diseases, highly irregular astigmatism, chronic uveitis, obvious abnormalities of the lens capsule and zonules, as well as patients with severe amblyopia; 3. Patients with severe photophobia not caused by cataracts; 4. Patients requiring other ophthalmic surgeries, such as glaucoma surgery combined with cataract extraction, or cataract extraction combined with vitreoretinal surgery; 5. Patients with a history of ocular trauma or eye surgery; 6. Patients with anxiety or perfectionist personality traits; patients with concomitant mental or psychological disorders; 7. Intraoperative posterior capsule rupture where IOL cannot be implanted centrally in the capsule.

Design outcomes

Primary

MeasureTime frame
Binocular uncorrected full-range visual acuity;

Secondary

MeasureTime frame
Visual Function Index (VFI-14) scores, spectacle independence status, and patient satisfaction;Near stereopsis;Contrast sensitivity;itrace visual quality analysis results;

Countries

China

Contacts

Public ContactLiu Chunling

West China Hospital of Sichuan University

chunlingsc@163.com+86 10 1234 5678

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 1, 2026