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Multicenter clinical trial to evaluate the efficacy and safety of multifocal intraocular lens (PMEA60)

Multicenter clinical trial to evaluate the efficacy and safety of multifocal intraocular lens (PMEA60)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200067198
Enrollment
Unknown
Registered
2022-12-29
Start date
2023-02-01
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Cataract

Interventions

Experimental group:Implantation of multifocal intraocular lens (PMEA60)
Control group:Implantation of multifocal intraocular lens (AT LISA tri 839MP)

Sponsors

Eye Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: (1) Aged 18 to 85 years, male or female; (2) Patients who are expected to undergo phacoemulsification and intraocular lens implantation; (3) LOCS III nuclear grade = 4; (4) The expected refractive power of the intraocular lens to be expected is +5.0D~+32.0D; (5) The best corrected distance visual acuity is less than 0.5 (decimal visual acuity); (6) Be able to understand the purpose of the clinical trial, participate voluntarily and sign the informed consent form by the patient himself or his legal guardian, and be able to complete the postoperative follow-up on time.

Exclusion criteria

Exclusion criteria: (1) Corneal endothelial cell count is less than 2000 cells/mm2; (2) Patients with preoperative fasting blood glucose >=8.3mmol/L; (3) There is a history of trauma that affects visual function, history of intraocular surgery or history of refractive corneal surgery; (4) Patients with strabismus, amblyopia or nystagmus; (5) Patients concomitant with other eye diseases judged by the investigator to be unsuitable for phacoemulsification and multifocal intraocular lens implantation. (6) Other circumstances judged by the investigator to be unsuitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Corrected distance visual acuity;Distance-corrected intermediate visual acuity;Distance-corrected near visual acuity;

Countries

China

Contacts

Public ContactAyong Yu

Eye Hospital of Wenzhou Medical University

qiuzhenghong@3healthcare.com0577-88068888

Outcome results

None listed

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