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Toric Intraocular Lens for the Safety and Efficacy of Cataracts Multicenter, Randomized, Open, Positive Parallel Control Clinical Validation

Toric Intraocular Lens for the Safety and Efficacy of Cataracts Multicenter, Randomized, Open, Positive Parallel Control Clinical Validation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-17013893
Enrollment
Unknown
Registered
2017-12-13
Start date
2014-03-31
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

Experimental group:Promeon Toric IOL

Sponsors

Capital Medical University Affiliated Beijing Tongren Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 88 Years

Inclusion criteria

Inclusion criteria: 1) Aged 18 years old or older, male or female; 2) Patients with cataract who are expected to undergo cataract phacoemulsification + IOL implantation have a hardness of 1 to 3 in the surgical eye nucleus; 3) preoperative corneal astigmatism is not less than 0.50D; 4) The expected refractive power of the intraocular lens is between + 5.0D and + 36.0D; 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) ophthalmology combined with other eye diseases There are contraindications for implantation of intraocular lenses, such as small or large eyeballs, malignant glaucoma, severe corneal dystrophy, uncontrollable over-pressure, overt macula / pigmented epithelium Cytopathology, diabetic retinopathy, severe optic atrophy, massive vitreous loss, chronic or severe uveitis, severe anterior chamber superficiality, choroidal hemorrhage, posterior capsular rupture or ciliary band separation (intraocular lens fixation) Color vision defects, and other serious eye diseases; 2) corneal irregular astigmatism surgery; 3) with severe or unstable heart, liver, kidney, lung, endocrine (including thyroid dysfunction), blood, mental disorders such as mental disorders; 4) surgery eyes had retinal detachment or retinopathy; 5) surgery eye traumatic cataract or congenital bilateral cataract patients; 6) electrocardiogram or laboratory test results suggest that surgical contraindications; 7) unattended or unable to follow the doctor's advice; 8) surgery eye nearly 3 months had eye injury or intraocular surgery history; 9) who need eye joint surgery; 10) Participate in other drug or medical device clinical trials within 30 days prior to screening; 11) Patients in need of eye or systemic medication that may affect vision during use or study; 12) Pregnant or lactating women; 13) the researchers judged the contralateral eye ignores the function; 14) Diabetic patients; 15) 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 Tong

drxdsong@sina.com+86 13901328779

Outcome results

None listed

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