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 @ 5:13 PM
Ignite Modification Date:
2025-12-24 @ 5:13 PM
NCT ID:
NCT01025050
Eligibility Criteria:
Inclusion Criteria:
* Age: at least 18 years old
* Patients must have read, understood and signed the Patient Information
* Patients are willing and able to return for follow-up examinations
* Stable distance refraction
* Manifested Refraction (see Table 1 for more details) :
* Cylinder: -0.5 D to 0 D
* Sphere: 0.25 D to 1.25 D
* Spherical equivalent: Minimum 0.25 D
* Best corrected distance visual acuity of the eye to be treated at least 0.8
* Subjects must have presbyopia as determined by an age-related need for optical aid (≥ +1.5 D) for reading with their best distance correction.
Exclusion Criteria:
* Minimum cornea thickness \< 500 µm
* Ocular dominance (only non-dominant eyes should be included)
* Uncorrected Near Visual Acuity of 0.5 or better
* Difference between manifested and cycloplegic refraction of \> 0.75 D in spherical equivalent
* Median K values \< 40 D or \> 46 D
* Topographical astigmatism \> 5 D
* Abnormal corneal topography
* Patients with previous corneal operations on the eye to be treated (e.g. LASIK, PRK, X-Linking; this does not include cataract operations)
* Scarring or opacity of the cornea
* Transplanted cornea
* Connective tissue weaknesses
* Keratectasia and other diseases of the cornea
* Patients with wound-healing disorders such as connective tissue disease, autoimmune illnesses, immunodeficiency illnesses, ocular herpes zoster or simplex, endocrine diseases, lupus, rheumatoid arthritis
* Patients regularly taking medicines that could influence the result of the treatment
* Glaucoma or a risk of glaucoma
* Patients with concentration disorders, epilepsy, diabetes mellitus and other complicating diseases
* Patients with disorders of the ocular muscle, such as nystagmus or strabismus
* Sensitivities to the drugs used in this study
* Continual wearing of contact lenses before the pre-examination and before the operation. Patients must refrain from wearing contact lenses for at least 14 days prior to these dates
* Patients who are pregnant or are lactating
* Patients who are participating in another ophthalmological clinical study
* Best corrected distance visual acuity of the second, not to be treated eye is 0.5 or less.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01025050
Study Brief:
Protocol Section:
NCT01025050