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 @ 10:55 PM
Ignite Modification Date:
2025-12-24 @ 10:55 PM
NCT ID:
NCT06506669
Eligibility Criteria:
Inclusion Criteria:
1. ≥ 60 years old
2. Capable of providing informed consent and completing the study procedures in English
3. Able to provide consent for oneself
4. Able to follow directions
5. Able to climb one flight of stairs without stopping to rest
6. Have a new diagnosis of cataract disease
7. Plan on having cataract surgery on their eye within the next 6 months
Exclusion Criteria:
1. History of prior cataract surgery
2. Admission to the hospital within the past 30 days
3. Difficulty being sedated during other minor outpatient procedures or imaging studies
4. Allergy or resistance to local anesthetic agents
5. Cannot lay flat on your back without having symptoms (i.e., difficulty breathing, severe back pain, etc.)
6. History of severe anxiety requiring routine use of benzodiazepines
7. Severe valve disease (e.g., critical aortic stenosis)
8. Cardiac conditions requiring an implanted cardiac device such as a pacemaker, defibrillator, or left ventricular assist device (for arrhythmia, congestive heart failure, etc.)
9. Untreated chest pain or angina
10. Patients with movement disorders (e.g., Parkinson's Disease)
11. History of Cerebral Vascular Accident (CVA), Transient Ischemic Attack (TIA), or seizures
12. Require home oxygen (O2) at rest or with exertion
13. End-stage renal disease (ESRD) requiring dialysis
14. Morbid obesity (BMI\>35)
15. Patient undergoing cataract surgery in combination with any other ophthalmologic procedure
16. Patient requiring general anesthesia during cataract surgery due to the underlying characteristics of the existing cataract and/or anticipated complexity of the planned procedure
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT06506669
Study Brief:
Protocol Section:
NCT06506669