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Multicenter, randomized, open, parallel controlled clinical trial of diffracted multifocal iOL for correction of acystal vision after cataract extraction

Multicenter, randomized, open, parallel controlled clinical trial of diffracted multifocal iOL for correction of acystal vision after cataract extraction

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400081982
Enrollment
Unknown
Registered
2024-03-18
Start date
2022-04-20
Completion date
Unknown
Last updated
2024-03-25

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

Conditions

Cataract

Interventions

Control group:The control group diffractive multifocal intraocular lens was implanted
The test grou:Diffractive multifocal intraocular lens of the experimental group was implanted

Sponsors

Eye Hospital, WMU Zhejiang Eyehospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 81 Years

Inclusion criteria

Inclusion criteria: 1. Age = 18 years old; age =81 years old,gender unlimited; 2. For patients with cataract in one or both eyes, who plan to undergo phacoemulsification + intraocular lens implantation and have delens requirements, the affected eye with poor corrected vision or better fundus is selected to be enrolled in this study if both eyes of the patient meet the admission criteria. 3. Kappa Angle < 0.5mm or Kappa Angle less than half of the diameter of the refraction optical region in the center of the diffractive multi-focal intraocular lens (Kappa Angle: the distance from the center of the pupil to the optic axis); 4. The Total high-order aberration (Total HOA) in the central corneal diameter of 4 mm was less than 0.3um; 5.3.0mm= natural pupil diameter under dark room =5.5mm; 6. Preoperative depth of anterior room = 2.00mm; 7. The axial length of the preoperative eye was 21 mm~28 mm; 8. Predicted corneal astigmatism =1.0D after surgery; 9. Intraocular lens correction diopter is expected to be between +5.0D and +30.0D; 10. Patients who can complete 12 months of follow-up; 11. Be able to understand the purpose of the trial, voluntarily participate in the clinical trial and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women, and those who plan to become pregnant within 12 months after the operation; 2. Preoperative best corrected far vision, middle vision under best corrected far vision, or near vision under best corrected far vision >20/40 (LogMAR chart); 3. Preoperative corneal endothelial cell count 8 mmol/L), or a history of diabetes associated with eye diseases or conditions affecting postoperative vision; 19. Results of electrocardiogram or laboratory examination indicate contraindications to surgery; 20. Unsupervised or unable to follow medical advice; 21. Other conditions that the investigator judged unsuitable for participation in the experiment.

Design outcomes

Primary

MeasureTime frame
The percentage of best corrected far vision, medium vision under best corrected far vision, and near vision under best corrected far vision all reach 20/40;

Secondary

MeasureTime frame
Best corrected far vision, medium vision under best corrected far vision, and near vision under best corrected far vision;

Countries

China

Contacts

Public ContactAyong Yu

Eye Hospital, WMU Zhejiang Eyehospital

yaybetter@hotmail.com+86 138 6876 0001

Outcome results

None listed

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