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 @ 2:50 AM
Ignite Modification Date:
2025-12-25 @ 2:50 AM
NCT ID:
NCT05147233
Eligibility Criteria:
Inclusion Criteria:
* Be planning to undergo unilateral cataract extraction via phacoemulsification and posterior chamber intraocular lens (PCIOL) implantation in the study eye.
* Have a pin-hole visual acuity (VA) without any other correction \> 20 letters (approximately 20/400) in the operative eye and \> 35 letters (approximately 20/200) in the fellow eye as measured using an Early Treatment for Diabetic Retinopathy Study (ETDRS) chart at Visit 1 (Day -1 to Day -28 \[prior to surgery\]).
Exclusion Criteria:
* Have any intraocular inflammation (e.g. white blood cells or flare) present in either eye at the Visit 1 (Day -1 to Day -28 \[prior to surgery\]) slit lamp examination.
* Have a score \> 0 on the Ocular Pain Assessment at Visit 1 (Day -1 to Day -28 \[prior to surgery\]) in the study eye.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05147233
Study Brief:
Protocol Section:
NCT05147233