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Aspherical diffractive multifocal intraocular lens for the safety and efficacy of cataract surgery Multicenter, randomized, open, positive parallel controlled clinical validation

Aspherical diffractive multifocal intraocular lens for the safety and efficacy of cataract surgery Multicenter, randomized, open, positive parallel controlled clinical validation

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OOC-17013895
Enrollment
Unknown
Registered
2017-12-13
Start date
2015-12-31
Completion date
Unknown
Last updated
2017-12-18

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

Conditions

cataract

Interventions

Case series:aspirin-type multifocal intraocular lenses

Sponsors

Capital Medical University Affiliated Beijing Tongren Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1) above 18 years old, male or female; 2) Patients with cataract who are expected to have cataract phacoemulsification + multifocal intraocular lens implantation have a 1 to 3 ophthalmic hardness; 3) need to remove the glasses of patients; 4) The refractive power of the intraocular lens is expected to be between + 6.0D and + 30.0D; 5) To be able to understand the purpose of the test, participate voluntarily and sign the informed consent form by the patient or his legal guardian.

Exclusion criteria

Exclusion criteria: 1) with other eye diseases, contraindications for implanted multifocal intraocular lenses, such as small or large eyeball, small pupil, malignant glaucoma, severe corneal dystrophy, uncontrollable intraocular pressure is too high, obviously Macular / pigmented epithelial cell lesions, diabetic retinopathy, severe optic atrophy, massive vitreous loss, chronic or severe uveitis, severe anterior superficial hypochondria, choroidal hemorrhage, posterior capsular rupture or ciliary lesion (can not be fixed Intraocular lens), and other serious ocular diseases associated with; 2) those with severe or unstable heart, liver, kidney, lung, endocrine (including thyroid insufficiency), blood, mental disorders; 4) corneal endothelial cell count less than 2000 / mm2; 5) corneal irregular astigmatism or corneal astigmatism greater than 1.0 in patients; 6) surgery eyes had retinal detachment or retinopathy patients; 7) traumatic cataract or congenital bilateral cataract patients; 8) surgery eye nearly 3 months had eye injury or intraocular surgery history; 9) ophthalmic surgery patients who had corneal surgery; 10) Patients who are used to wearing glasses to read; 11) occupational needs or daily life over the visual function of those who; 12) Professional drivers or regular outdoor workers at night; 13) Patients with a history of photophobia; 14) for those who have excessive vision after surgery, or who are overly sensitive, nervous, depressed, or critical; 15) surgery found that the anterior lens capsule rupture or posterior capsule rupture intraocular lens implantation can not be encapsulated in patients; 16) who need eye joint surgery; 17) ECG or laboratory test results suggest that surgical contraindications; 18) Participate in other drug or medical device clinical trials within 30 days prior to screening; 19) Patients in need of eye or systemic medication that may affect vision during use or study; 20) Pregnant or lactating women; 21) unattended or unable to follow the doctor's advice; 22) Other conditions in which the researcher judged the patient unsuitable for inclusion.

Design outcomes

Primary

MeasureTime frame
vision;

Countries

China

Contacts

Public ContactNingli Wang

Capital Medical University Affiliated Beijing Tongren Hospital

drxdsong@sina.com+86 13901328779

Outcome results

None listed

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