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 @ 11:32 PM
Ignite Modification Date:
2025-12-24 @ 11:32 PM
NCT ID:
NCT05739656
Eligibility Criteria:
Inclusion Criteria:
* Subjects must be able to read, understand, and provide written informed consent on the Institutional Review Board (IRB)-approved Informed Consent Form (ICF) and provide authorization as appropriate for local privacy regulations.
* Subjects must be able and willing to comply with all treatment and follow-up/study procedures.
* Subjects must be 18 years of age or older on the date the ICF is signed.
* Subjects must have best-corrected distance visual acuity (BCDVA) equal to or worse than 20/40 in the study eye, with or without glare source, due to a clinically significant cataract (either cortical, nuclear, subcapsular, or a combination) that is considered amenable to treatment with standard phacoemulsification cataract extraction.
* Subjects must require a spherical equivalent lens power from 17.0 D to 24.0 D in the study eye.
* Subjects must have a BCDVA projected to be better than 20/30 after toric IOL implantation in the study eye (as determined by the medical judgment of the Investigator or measured by potential VA testing if necessary).
* Subjects must have a preoperative corneal astigmatism between 0.77 D and 4.53 D in the study eye.
* Subject must have a dilated preoperative pupil size greater than or equal to 5.0 mm in the study eye.
* Contact lens wearers need to demonstrate a stable refraction (within
±0.50 D) in the study eye, as determined by manifest refraction spherical equivalent (MRSE) on two consecutive examination dates. Stability of the refraction is determined under the following conditions:
\- Lenses are not worn for at least 2 weeks (rigid or toric contact lenses) or 3 days (soft contact lenses) prior to the first refraction used to establish stability and through the day of surgery.
* The two refractions are performed at least 7 days apart.
Exclusion Criteria:
This study will exclude subjects who meet none of the following exclusion criteria:
* Subjects with any anterior segment pathology in the study eye likely to increase the risk of complications from phacoemulsification cataract surgery (eg, chronic uveitis, iritis, iridocyclitis, rubeosis iridis, clinically significant corneal dystrophy, clinically significant Fuchs' dystrophy, clinically significant anterior membrane dystrophy, etc).
* Subjects with associated ocular conditions which could affect the stability of the IOL (eg, traumatic zonulolysis, zonular dialysis, evident zonular weakness or dehiscence, etc) in the study eye.
* Subjects with clinically significant irregular corneal astigmatism in the study eye, as determined by the medical judgment of the Investigator.
* Subjects with clinically significant corneal pathology potentially affecting topography of either eye.
* Subjects with any ocular condition (eg, amblyopia) that could prevent the possibility of a visual outcome better than 20/30 in the study eye.
* Subjects with an anterior chamber depth \< 2.0 mm as measured by the IOL master/LENSTAR in the study eye.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05739656
Study Brief:
Protocol Section:
NCT05739656