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 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 12:40 AM
NCT ID:
NCT07137767
Eligibility Criteria:
Inclusion Criteria:
* Adults aged 40-65 years
* Healthy cornea
* Refractive error between +4.0 D and -5.0 D
* Phakic or monofocal pseudophakic (≥6 months post IOL placement)
* Visual acuity correctable by ±0.25 D
Exclusion Criteria:
* Corneal dystrophy, scarring, or prior corneal crosslinking
* Astigmatism \>1.0 D
* Active ocular infection, inflammation, or uncontrolled dry eye
* Advanced glaucoma or diabetic retinopathy
* History of delayed corneal healing
* Pregnancy, breastfeeding, or planning pregnancy during study period
* Certain medications (e.g., isotretinoin)
* Recent participation in other investigational drug/device studies (within 30 days)
* Patients with uncontrolled dry eye or surface disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
65 Years
Study:
NCT07137767
Study Brief:
Protocol Section:
NCT07137767