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 @ 3:29 PM
Ignite Modification Date:
2025-12-24 @ 3:29 PM
NCT ID:
NCT06597292
Eligibility Criteria:
Inclusion Criteria
Subjects who meet all of the following criteria are candidates for this study:
1. Male or Female
2. Any race
3. Patient is at least 40 years old.
4. Patient is pseudophakic or is phakic with no clinically significant cataract in eye(s) to be treated.
5. Patient has manifest refraction, spherical equivalent (MRSE) between -0.50 D to 2.50 D, with no more than 1.0 D of refractive cylinder, in eye(s) to be treated.
6. Patient has uncorrected distance visual acuity (UDVA) of 20/100 or better (i.e., LogMAR ≤ 0.70) in both eyes.
7. Patient has best corrected distance visual acuity (CDVA) of 20/20 or better (i.e., LogMAR ≤ 0.00) in both eyes.
8. Patient has uncorrected near visual acuity (UNVA) between 20/50 (LogMAR 0.40) and better than 20/100 (LogMAR \< 0.70) in eye(s) to be treated.
9. Patient has best corrected near visual acuity (CNVA) of at least 20/20 (LogMAR ≤ 0.00) in eye(s) to be treated.
10. Patient requires reading adds of +1.0 to +3.0 D in eye(s) to be treated.
11. Patient is not a contact lens (CL) wearer.
12. Patient has normal corneal topography.
13. Patient is willing and able to comply with all examinations.
14. Patient must be competent to sign an informed consent form before study entry.
Exclusion Criteria
Subjects who meet any of the following criteria are to be excluded from this study:
1. Corneal disease or corneal disorder in either eye.
2. Any active ocular surface disease of any severity.
3. Increased IOP (above 20 mm Hg), glaucoma or history of glaucoma.
4. Previous corneal surgery in the eye to be treated.
5. Conjunctivochalasis
6. Nystagnus
7. Diabetes
8. Pregnancy
9. Presence or history of any other condition or finding that, in the opinion of the investigator, makes the patient unsuitable as a candidate for study participation or that may confound the outcome of the study.
nclusion Criteria: -
Exclusion Criteria:
\-
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT06597292
Study Brief:
Protocol Section:
NCT06597292