Skip to content

Intraocular lens (aspherical) is used for the safety and efficacy of cataract extraction with multiple centers, randomized, open, and positive parallel controlled clinical trials

Intraocular lens (aspherical) is used for the safety and efficacy of cataract extraction with multiple centers, randomized, open, and positive parallel controlled clinical trials

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-17013925
Enrollment
Unknown
Registered
2017-12-14
Start date
2013-04-08
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

Arm A:RS60A, RS57A and RS55A
Arm B:Control products

Sponsors

Beijing Tongren Hospital Affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Age 18-75, male and female; Monocular or binocular with cataracts, and expectations for cataract ultrasonic emulsification + patients with intraocular lens implantation, the extraction for patients with eyes, choose the heavier that only with eyes into the group of this research; It is expected that the corrected diopter of intraocular lens is between 0.0D and +34.0 D; To be able to understand the purpose of the test, to participate voluntarily and to sign the informed consent form by the patient himself or his legal guardian.

Exclusion criteria

Exclusion criteria: With other eye diseases, such as congenital microphthalmia, glaucoma, corneal malnutrition, macular degeneration/pigment epithelial lesions, diabetic retinopathy, optic atrophy, and chronic uveitis, serious too shallow anterior chamber, choroid bleeding, ciliary zonule separating fixed intraocular lens (can't), etc.; The eye has retinal detachment or retinopathy; Traumatic cataract or congenital bilateral cataract; Need eye joint operation; The researchers determined that the non-operative eye ignored the function; The corneal endothelial cell count is less than 1000 / mm2; Patients with ocular trauma or intraocular surgery for nearly 3 months; Participated in other drug or medical device clinical trials within 30 days of screening;Patients with severe or unstable heart, liver, kidney, lung, endocrine (including incomplete thyroid function), blood, mental and neurological disorders, etc.; The results of an electrocardiogram or laboratory examination may indicate that there are surgical contraindications; diabetic; ALTAST exceeds the normal value limit of 1.5 times, creatinine exceeds the normal value upper limit; The use of local or systemic drugs may affect the visual acuity during or during the study period; Planned to be pregnant within six months; Unsupervised or unable to follow the doctor's orders; The researchers judged that patients were not eligible for other situations.

Design outcomes

Primary

MeasureTime frame
best corrected distant visual acuity;

Countries

China

Contacts

Public ContactNingli Wang

Beijing Tongren Hospital Affiliated to Capital Medical University

wningli@vip.163.com+86 13511026669

Outcome results

None listed

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