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A multicenter, randomized, open, parallel-controlled trial of lengthening depth of field intraocular lens for visual acuity correction after cataract extraction

A multicenter, randomized, open, parallel-controlled trial of lengthening depth of field intraocular lens for visual acuity correction after cataract extraction

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071151
Enrollment
Unknown
Registered
2023-05-06
Start date
2023-05-01
Completion date
Unknown
Last updated
2023-06-04

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

Conditions

Cataract

Interventions

trial group:Implanting depth-of-field elongated intraocular lens
control group:Implanting TECNIS?Symfony Extended Range of Vision IOL

Sponsors

Eye Hospital, WMU Zhejiang Eyehospital
Lead Sponsor

Eligibility

Sex/Gender
All

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 and intraocular lens implantation and have the requirement of delens, if both eyes of the patient meet the admission criteria, the affected eye with poor corrected vision or better fundus is selected to be enrolled in this study; (3) Kappa Angle < 0.7mm (Kappa Angle: distance from pupil center to 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 =5.5mm in dim; (6) Preoperative depth of anterior room =2.00 mm; (7) Postoperative predicted corneal astigmatism =1.0D; (8) The expected intraocular lens refraction was between +5.0D and +30.0D; (9) Patients who were able to complete 6-month follow-up; (10) 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 6 months after the operation; (2) The best corrected distal visual acuity >20/40 (LogMAR visual acuity 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) Electrocardiogram or laboratory examination results 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
At 6 months after surgery, optimal corrected distal vision and middle vision A under optimal corrected distal vision were obtained Percentage of patients with 20/40 visual acuity (80cm) and medium visual acuity B (60cm) (LogMAR visual acuity chart was used uniformly in each center);contrast sensitivity;

Secondary

MeasureTime frame
diopter;Defocus curve;Visual B (60cm) detachment rate;Visual Symptom Survey;

Countries

China

Contacts

Public ContactAyong Yu

Eye Hospital, WMU Zhejiang Eyehospital

yaybetter@hotmail.com+86 13868760001

Outcome results

None listed

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