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:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2025-12-24 @ 7:32 PM
NCT ID:
NCT02890303
Eligibility Criteria:
Inclusion Criteria:
1. Subjects must be age 22 or older,
2. Subjects consenting to undergoing phacoemulsification and IOL implant surgery for the treatment of symptomatic age related lens cataract, and then electing to undergo ZeptoTM capsulotomy,
3. Subjects must be willing and able to return for scheduled treatment and follow-up examinations for 3 months.
Exclusion Criteria:
1. Disease or pathology in the treatment eye that will compromise visual performance or refractive outcome (e.g. previous refractive surgery),
2. Zonular abnormality,
3. Posterior polar cataract,
4. Fellow eye with acuity less than 20/200,
5. Any prior ocular surgery of the study eye,
6. Pupillary dilation during the pre-operative exam of less than 7 mm in diameter,
7. Proliferative diabetic retinopathy,
8. Disorders of the ocular muscles, such as nystagmus or strabismus,
9. Chronic uveitis,
10. Abnormal corneal endothelium,
11. Subjects on medications with, in the opinion of the surgeon, significant ocular side effects,
12. Pregnant or nursing (lactating) women,
13. Implanted ocular device or drug in the study eye,
14. Any other condition, which in the judgment of the investigator would prevent the subject from completing the study (e.g. documented diagnosis or treatment for symptoms associated with dementia, mental illness),
15. Current participation in another drug or device clinical study, or participation in such a clinical study within the six months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT02890303
Study Brief:
Protocol Section:
NCT02890303