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 @ 5:04 AM
Ignite Modification Date:
2025-12-25 @ 5:04 AM
NCT ID:
NCT04907318
Eligibility Criteria:
Inclusion Criteria:
* Cataract (with or without presbyopia)
* No pre-existing ocular pathology or history of ocular surgery
* No phacodonesis
PEX patients (pseudoexfoliation syndrome) can be included.
Exclusion Criteria:
To ensure equivalence of the two comparable groups, the patients with potential postoperative visual acuity less than 5/10, particularly due to an insufficient retinal function or poor corneal condition will be excluded.
In particular the patients with the following pathologies will be excluded:
* Irregular astigmatism.
* Cases of uncontrolled glaucoma.
* Intraocular inflammation.
* Narrow anterior chambers (2.5 mm).
* Amblyopia with potential visual acuity less than 5/10.
* Any corneal pathology potentially affecting topography (e.g., keratoconus).
* Patients with a history of corneal surgery (especially refractive surgery).
* Patients with diagnosed degenerative visual disorders (e.g., macular degeneration, diabetic retinopathy or other retina diseases or surgery) with known negative impact on visual function possibly leading to visual acuity levels below 0.5.
* Patients with a history of ocular trauma.
* Pathological miosis.
* Patients with zonular laxity.
* Patients suffering from chronic uveitis.
* Patients with monophthalmia. Capsule rupture, intraocular haemorrhage, excessive loss of vitreous, vitreous flare, soft capsules during cataract surgery are also exclusion criteria.
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT04907318
Study Brief:
Protocol Section:
NCT04907318