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 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT03900260
Eligibility Criteria:
Inclusion Criteria:
1. ≥ 21 years of age, of any race and either gender
2. Operable, age related cataract grade in one or both eyes
3. Patients who require an IOL power in the range of 10.0 - 30.0 D only
4. Able to comprehend and sign a statement of informed consent
5. Planned cataract removal by phacoemulsification
6. Potential postoperative visual acuity of 0.2 logMAR or better
7. No other ocular or systemic pathology that may affect visual outcome following cataract surgery
8. Clear intraocular media other than cataract in study eyes
9. Preoperative Best Corrected Visual Acuity (BCVA - VA taken with original manifest refraction) worse than 0.2 logMAR
10. Able to competently complete testing
11. Willing and able to attend study visits
Exclusion Criteria:
1. Previous intraocular surgery
2. Previous corneal refractive surgery
3. Any inflammation or oedema (swelling) of the cornea
4. Pterygium with corneal involvement or has the potential of corneal involvement (in the opinion of the Investigator)
5. Amblyopia
6. Clinically significant ptosis
7. Clinically severe corneal dystrophy (e.g. epithelial, stromal, or endothelial dystrophy), keratitis, keratoconjunctivitis, keratouveitis, keratopathy, or kerectasia
8. Diabetic Retinopathy
9. Previous retinal detachment
10. Previous corneal transplant
11. Iris neovascularization
12. Glaucoma (medically controlled or uncontrolled)
13. Aniridia
14. Chronic severe uveitis
15. Optic nerve atrophy
16. Corneal decompensation
17. History of corneal disease (e.g. herpes simplex, herpes zoster keratitis, etc.)
18. Pseudoexfoliation syndrome
19. Iris atrophy
20. Aniseikonia
21. Pregnant, lactating, or planning to become pregnant during the course of the trial Note: Patients who become pregnant during the study will not be discontinued; however, data may be excluded from the effectiveness analyses because pregnancy can alter refraction and visual acuity results.
22. Participation in another clinical trial within 30 days of study start
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT03900260
Study Brief:
Protocol Section:
NCT03900260