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 @ 1:47 PM
Ignite Modification Date:
2025-12-24 @ 1:47 PM
NCT ID:
NCT03633695
Eligibility Criteria:
Inclusion Criteria:
1. Minimum 22 years of age;
2. Able to comprehend and have signed a statement of informed consent;
3. Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visits;
4. Planned crystalline lens removal by phacoemulsification, with or without femtosecond laser-assisted extraction, and posterior chamber IOL implantation in both eyes;
5. Cataractous lens changes as demonstrated by best-corrected visual acuity (BCDVA) of 20/40 or worse either with or without a glare source present;
6. Potential for postoperative BCDVA of 20/25 or better in each eye
7. Clear intraocular media, other than cataract.
Exclusion Criteria:
1. Requiring an IC-8 intraocular lens outside the available spherical power range
2. Pharmacologically dilated pupil size less than 6 mm in either eye;
3. Inability to achieve stable keratometric readings for contact lens wearers
4. Irregular astigmatism in either eye;
5. Preoperative corneal astigmatism \> 1.50 diopters in either eye
6. Active or recurrent anterior segment pathology
7. Presence of ocular abnormalities other than cataract as specified in the protocol
8. Diagnosis of dry eye in which patients are unable to maintain eye comfort or adequate vision even with dry eye medication;
9. Congenital cataracts;
10. Previous corneal or intraocular surgery
11. History of ocular trauma or ocular conditions expected to require retinal laser treatment or other surgical intervention;
12. Systemic conditions as specified in the protocol;
13. Patient is pregnant, plans to become pregnant, or is lactating
14. Concurrent participation or participation in any clinical trial up to 30 days prior to preoperative visit.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT03633695
Study Brief:
Protocol Section:
NCT03633695