Status:
COMPLETED
Clinical Validation Plan of Capsular Tension Ring
Lead Sponsor:
Eyebright Medical Technology (Beijing) Co., Ltd.
Conditions:
Intraocular Lens Implantation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Through follow-up for 1 year or more, the safety and effectiveness of the Capsular Tension Ring produced by Eyebright Medical Technology (Beijing) Co., Ltd. were verified, which is used for intraocula...
Detailed Description
According to the principle of "Quality management standard for clinical trials of medical devices" issued by CFDA, a multi-center, randomized, open, positive product, parallel controlled trial design ...
Eligibility Criteria
Inclusion
- Over 18 years old, no gender limit;
- For cataract patients who are expected to undergo phacoemulsification + Capsular Tension Ring and intraocular lens implantation, the hardness of the surgical eye nucleus is 1 to 3;
- Be able to understand the purpose of the trial, voluntarily participate in and sign informed consent form by the patient himself or his legal guardian.
Exclusion
- Inclusion criteria
- Over 18 years old, no gender limit;
- For cataract patients who are expected to undergo phacoemulsification + Capsular Tension Ring and intraocular lens implantation, the hardness of the surgical eye nucleus is 1 to 3;
- Be able to understand the purpose of the trial, voluntarily participate in and sign informed consent form by the patient himself or his legal guardian.
- Exclusion criteria
- The surgical eye has other ocular diseases, those with Capsular Tension Ring implantation or intraocular operation contraindications, such as binocular congenital cataracts, microphthalmia, children under the age of 12 months, corneal dystrophy or endothelial cell insufficiency, chronic uveitis, active ocular diseases (Diabetic retinopathy active stage, uncontrollable glaucoma), fragile capsular bag, zonular rupture exceeding 120 degrees, etc.
- Accompanied by severe or unstable heart, liver, kidney, lung, endocrine (including thyroid insufficiency), blood, mental and nerve dysfunction and other diseases;
- The surgical eye has had retinal detachment or retinopathy;
- Patients with congenital cataracts undergoing operation;
- Those whose electrocardiogram examination or laboratory examination results suggest surgical contraindications;
- Those who are unsupervised or cannot follow the doctor's advice;
- Those with a history of intraocular operation in the last 3 months;
- It is estimated that the best corrected distance visual acuity after operation is less than 20/40;
- Those who need combined eye operation;
- Participated in clinical trials of other drugs or medical devices within 30 days before screening;
- Patients who are using or need to use ocular or systemic drugs during the research period that may affect their visual acuity;
- Pregnant or breastfeeding women;
- Those who have been judged by the researcher to ignore the function of the contralateral eye;
- The researcher judges that the patient is not suitable for other situations.
Key Trial Info
Start Date :
May 21 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 24 2017
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04880018
Start Date
May 21 2015
End Date
October 24 2017
Last Update
May 10 2021
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