Prospective, multicenter, randomized, single blind, positive controlled, non inferiority clinical trial of hydrophobic acrylic multifocal intraocular lens for cataract extraction safety and efficacy

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000038240

Enrollment

Unknown

Registered

2020-09-15

Start date

2020-10-30

Completion date

Unknown

Last updated

2020-12-07

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

Conditions

Cataract

Interventions

Trial group:Multifocal Intraocular Lens

Control group:Intraocular Lens

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: l. The age of patients over 18 years old is not limited to men and women; 2. For patients with monocular or bilateral cataracts, those who are expected to undergo phacoemulsification and intraocular lens implantation and need to take off the lens, if both eyes of the patients meet the entry criteria, the one with poor corrected vision or better fundus will be selected for this study; 3. Patients with kappa angle < 0.5mm or kappa angle less than half of the diameter of MIOL central refractive optical area (kappa angle: distance from pupil center to optic axis); alpha angle < 0.5mm (distance from corneal center to optic axis); total higher-order aberrations (totalhoa) < 0.3um in areas with central corneal diameter of 4 mm; 4. Patients with expected corrected intraocular lens diopter between 0.0d and + 34.0d.

Exclusion criteria

Exclusion criteria: 1. Patients with best corrected visual acuity greater than 20 / 40; 2. Patients with other ocular diseases, such as congenital microphthalmos, glaucoma, corneal dystrophy, maculopathy / pigmented epithelial cell disease, diabetic retinopathy, severe optic atrophy, chronic uveitis, severe anterior chamber shallow, choroidal hemorrhage, posterior capsule rupture or ciliary band separation (unable to fix intraocular lens), etc; The patients had retinal detachment or had retinopathy; 4. Patients with traumatic cataract or congenital bilateral cataract; 5. The patients who need to be operated on; 6. According to the researcher's judgment, the patients who have no eye function or weakness.

Design outcomes

Primary

Measure	Time frame
Percentage of patients with 20/40 near vision under best corrected distance vision at 6 months after surgery;	—

Countries

China

Contacts

Public ContactXudong Song

Beijing Tongren Hospital Affiliated to Capital Medical University

drxdsong@sina.com+86 13901328779

Outcome results

None listed

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