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 @ 11:45 PM
Ignite Modification Date:
2025-12-24 @ 11:45 PM
NCT ID:
NCT03172351
Eligibility Criteria:
Inclusion Criteria:
* Patient informed of the consequences and constraints of the Clinical Investigational Plan and who has given his/her written informed consent;
* Patients of any gender, aged 50 to 80 years;
* Assured follow-up examinations;
* clinically significant bilateral cataract;
Exclusion Criteria:
* Patients unable to meet the limitations of the Clinical Investigational Plan or likely of non-cooperation during the trial;
* Patients whose freedom is impaired by administrative or legal order;
* Current participation in another drug or device investigation;
* Ocular disorders, other than cataract, that could potentially cause future acuity loss to a level of 0.20 logMAR (corrected) or worse in either eye
* Any anterior segment pathology that could significantly affect outcomes (e.g. chronic uveitis, iritis, corneal dystrophy, etc.)
* Pseudoexfoliations syndrome
* Pathologic miosis or Pharmacotherapy with miotic agent
* Keratoconus
* Chronic or recurrent uveitis
* Diabetic retinopathy
* Uncontrolled glaucoma and or IOP\>24mmHg
* Choroidal hemorrhage,
* All kind of infections (acute ocular disease, external/internal infection, systemic infection)
* Traumatic cataract
* Aniridia
* Microphthalmia
* Amblyopia
* Degenerative visual disorders (e.g. macular degeneration, optic nerve atrophy, or retinal disorders)
* Patient expected to require retinal laser treatment before the end of the 4-6 months follow-up
* Previous intraocular and corneal surgery
* Expected postop. astigmatism greater than 1 D
* Any type of corneal disorder
* Systemic or ocular pharmacotherapy, which can impact the visual acuity,
* Former, current or foreseeable application of Tamsulosin or Silodosin (e.g. Flomax, Flomaxtra, Rapflo) ) which potentially can cause the floppy iris syndrome, insufficient dilation, or missing of appropriate iris structures which can compromise the standard procedure according to the investigator's opinion
* Patients who are unable to fixate for longer time (e.g. strabismus, nystagmus)
* Dementia
* pregnancy or lactation period for female patients
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
80 Years
Study:
NCT03172351
Study Brief:
Protocol Section:
NCT03172351