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 @ 2:54 AM
Ignite Modification Date:
2025-12-25 @ 2:54 AM
NCT ID:
NCT03864133
Eligibility Criteria:
Inclusion Criteria:
* Adults age 55-90 years with visual significant cataracts in one or both eyes.
* Healthy individuals able to tolerate outpatient cataract surgery under local anesthesia via either phacoemulsification and/or femtosecond assisted cataract surgery. Well-controlled diabetes, hypertension will be included.
* Females of childbearing potential must agree to use a reliable method of birth control while participating in this study. Reliable methods of birth control are: abstinence, oral contraceptives, intrauterine device (IUD), DepoProvera, tubal ligation or vasectomy of the partner (with confirmed negative sperm counts) in monogamous relationship (same partner). An acceptable, although less reliable, method involves the careful use of condoms and spermicidal foam or gel and/or cervical cap or sponge. A pregnancy test is required at least 10 days from the last normal menstrual period, if the patient is a sexually active female of childbearing potential.
Exclusion Criteria:
* Allergy to Phenylephrine or NSAIDs.
* Inability to sit steady and upright for the Optical Coherence Tomography (OCT).
* Complications during surgery, including posterior capsular rupture, vitreous loss, zonular dialysis, or iris trauma.
* Macular thickness above 300 microns at baseline
* Currently taking a prostaglandin analogue
* Presence of an epiretinal membrane on the preoperative OCT.
* Retained lens fragment post-operatively.
* Inability to return for follow appointments
* Female patients who are pregnant, lactating or planning to become pregnant during the course of treatment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
90 Years
Study:
NCT03864133
Study Brief:
Protocol Section:
NCT03864133