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 @ 3:53 PM
Ignite Modification Date:
2025-12-24 @ 3:53 PM
NCT ID:
NCT07140692
Eligibility Criteria:
Inclusion Criteria:
1. Male or female participant with age ≥ 18 years at the time of screening.
2. Subjects with Posterior chamber Intraocular lens (PCIOL) in one or both the eyes (both eyes will be independently assessed).
3. Subjects must be able to understand and voluntarily provide written informed consent before screening, following an explanation of the nature and purpose of this study.
4. Subjects must be willing and able to comply with all treatment and follow-up study procedures.
5. Complaints of decreased vision/decreased quality of vision due to vitreous floaters which is having an impact on Activities of daily living (ADLs).
6. Documentation of vitreous opacities on Slit lamp exam/Dilated Fundus Exam (SLE/DFE).
7. Documentation of decreased DLI on iTrace.
Exclusion Criteria:
1. Subjects with history of retinal tear/detachment, macular edema, Epi-retinal membrane (ERM), vitreomacular traction syndrome (VMT), Age-related macular degeneration (AMD), Proliferative Diabetic Retinopathy (PDR), or other significant retinal disorders in procedural eye.
2. Subjects with History of trauma to operative eye.
3. Subjects with bleeding disorders or anticoagulation.
4. Subjects with history of ocular herpetic infections.
5. Female subjects of child bearing potential with positive urine pregnancy test.
6. Subjects who have participated in any drug or device clinical investigation within 30 days prior to entry into or during this study.
7. Any medical condition that would be contraindicated for cataract surgery.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07140692
Study Brief:
Protocol Section:
NCT07140692