Skip to content

Post-Market Clinical Study on Multifocal IOLs

Post-Market Clinical Study on Multifocal IOLs

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500104773
Enrollment
Unknown
Registered
2025-06-23
Start date
2025-07-01
Completion date
Unknown
Last updated
2025-06-30

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

Conditions

Cataract

Interventions

Experimental group :Multifocal intraocular lens of the experimental group was implanted

Sponsors

Shanghai General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 81 Years

Inclusion criteria

Inclusion criteria: 1. 18 years old< = age< = 81 years old, gender is not limited; 2. Patients with cataract in one or both eyes who are scheduled to undergo phacoemulsification removal of intraocular lens implantation and have a requirement for de-mirroring; 3. Kappa angle <0.6mm; 4. The total higher-order aberration (Total HOA) in the corneal diameter area of 4 mm in the center of the cornea <0.5um; 5. 3.0mm<=natural diameter of the subpupil in the darkroom<=5.5mm; 6. The axial length of the preoperative eye is 21 mm~28 mm; 7. Patients with predicted corneal astigmatism <=1.0D after surgery; 8. Able to understand the purpose of the trial, voluntarily participate in this clinical trial and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women, and those who plan to become pregnant within 12 months after the operation; 2. Preoperative corneal endothelial cell count 8.3 mmol/L), or a history of diabetes associated with eye diseases or conditions affecting postoperative vision; 16. Results of electrocardiogram or laboratory examination indicate contraindications to surgery; 17. Unsupervised or unable to follow medical advice; 18. Other conditions that the investigator judged unsuitable for participation in the experiment.

Design outcomes

Primary

MeasureTime frame
Best corrected distance visual acuity in both one and both eyes;The percentage of eyes with best corrected distance visual acuity (60 cm) and near visual acuity (40 cm) both reached 4.7;

Secondary

MeasureTime frame
The change status of monocular and binocular vision;Comparison of monocular and binocular contrast sensitivity under photopic and mesopic;Monocular and Binocular Visual Symptom Survey;Monocular and Binocular Near Vision Glasses Independence Rates;

Countries

China

Contacts

Public ContactHaidong Zou

Shanghai General Hospital

zouhaidong@263.net+86 133 1198 6528

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026