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 @ 5:10 AM
Ignite Modification Date:
2025-12-25 @ 5:10 AM
NCT ID:
NCT06991127
Eligibility Criteria:
Inclusion Criteria:
* Age: ≥18 years old;
* Best Corrected Visual Acuity (BCVA): ≥ 0.8 Decimal (≥ 20/25 ft, ≤ +0.1 logMAR) at least in the study eye;
* Equivalent spherical refraction between the range ≥ -6D and ≤ +6D; astigmatism within 2D (≤ 2D) at least in the study eye;
* Intraocular Pressure (IOP) ≤ 21 mmHg in both eyes (Goldmann applanation tonometer);
* Clinically normal appearance of the optic nerve head according to clinical judgement (no evidence of excavation, rim thinning, notching, disc hemorrhages, RNFL thinning) in both eyes. This is examined with Spectralis or Solix OCT;
* Clinically normal appearance of the macula according to clinical judgement, in both eyes. This is examined with Spectralis or Solix OCT;
* No ocular pathologies, trauma, surgeries (apart from uncomplicated cataract surgery or peripheral laser retinopexy performed at least 6 months before enrollment) in both eyes;
* Absence of pathologies that can affect visual field in both eyes;
* No use of drugs interfering with the correct execution of perimetry.
Exclusion Criteria:
* Glaucoma or glaucoma suspect diagnosis in either eye;
* Presence or history of ocular hypertension (IOP ≥ 22 mmHg) in either eye;
* Presence or history of disc hemorrhage in either eye;
* Presence of amblyopia in either eye;
* Nystagmus or poor fixation in either eye;
* Previous laser or any ocular surgery, including uncomplicated cataract surgery performed within 6 months before enrollment in both eyes;
* Any active infection of anterior or posterior segments in the study eye;
* Subjects with significant ocular media opacities preventing acquisition of acceptable infrared (IR) fundus image quality in the study eye;
* Evidence of diabetic retinopathy, diabetic macular edema, or other retinal disease in either eye;
* Use of any drug that can interfere with the correct execution of MP or that would produce visual field loss;
* Unable to tolerate ophthalmic imaging;
* Claustrophobia;
* Inability to provide informed consent.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06991127
Study Brief:
Protocol Section:
NCT06991127