Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:35 AM
Ignite Modification Date:
2025-12-25 @ 4:35 AM
NCT ID:
NCT04880018
Eligibility Criteria:
Inclusion Criteria:
1. Over 18 years old, no gender limit;
2. 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;
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:
Inclusion criteria
1. Over 18 years old, no gender limit;
2. 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;
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
1. 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.
2. Accompanied by severe or unstable heart, liver, kidney, lung, endocrine (including thyroid insufficiency), blood, mental and nerve dysfunction and other diseases;
3. The surgical eye has had retinal detachment or retinopathy;
4. Patients with congenital cataracts undergoing operation;
5. Those whose electrocardiogram examination or laboratory examination results suggest surgical contraindications;
6. Those who are unsupervised or cannot follow the doctor's advice;
7. Those with a history of intraocular operation in the last 3 months;
8. It is estimated that the best corrected distance visual acuity after operation is less than 20/40;
9. Those who need combined eye operation;
10. Participated in clinical trials of other drugs or medical devices within 30 days before screening;
11. Patients who are using or need to use ocular or systemic drugs during the research period that may affect their visual acuity;
12. Pregnant or breastfeeding women;
13. Those who have been judged by the researcher to ignore the function of the contralateral eye;
14. The researcher judges that the patient is not suitable for other situations.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04880018
Study Brief:
Protocol Section:
NCT04880018