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 @ 11:10 PM
Ignite Modification Date:
2025-12-24 @ 11:10 PM
NCT ID:
NCT05210569
Eligibility Criteria:
Subjects are eligible for the study if they meet the following criteria:
Note: Ocular criteria must be met in both eyes.
Inclusion Criteria:
* Undergoing uncomplicated bilateral cataract surgery with IOL implantation.
* Gender: Males and Females.
* Age: 50 years or older.
* Willing and able to provide written informed consent for participation in the study.
* Willing and able to comply with scheduled visits and other study procedures.
* Motivated for greater degree of spectacle independence vs monofocal IOL.
* Axial length ≥24.5mm in both eyes.
* Planned cataract removal by femtosecond laser.
Exclusion Criteria:
If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
* Ocular comorbidity that might hamper postoperative visual acuity.
* Previous refractive surgery.
* Irregular corneal astigmatism.
* Evidence of keratoconus as per Pentacam.
* Expected post-op VA worse than 20/25 (Snellen).
* Refractive lens exchange.
* Difficulties comprehending written or spoken English language.
* Patients with physical or intellectual disability (e.g. Down's Syndrome, Parkinson's Disease; unable to fixate).
* Clinically significant or severe ocular surface disease that would affect study measurements based on the investigator's opinion.
* Axial length \<24.5mm.
* Evidence of macular pathology as per optical coherence tomography examination.
The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.
Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT05210569
Study Brief:
Protocol Section:
NCT05210569