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 @ 9:15 PM
Ignite Modification Date:
2025-12-24 @ 9:15 PM
NCT ID:
NCT02561104
Eligibility Criteria:
Inclusion Criteria:
1. Referred for cataract surgery at Parkland Memorial Hospital
2. Potential post-operative visual acuity of 20/30 or greater determined by potential acuity meter (PAM) testing or modified super pinhole potential acuity of 20/30 or greater
3. Clear intraocular media other than cataract in study eye(s)
4. Subject eyes will have a dilated pupil diameter of at least 6 mm
5. Subject eyes will lack other pre-existing ocular pathology or condition that may confound treatment effects, including diabetic retinopathy, previous retinal detachment, iris neovascularization, amblyopia, optic nerve atrophy or recurrent severe anterior or posterior segment inflammation of unknown etiology.
Exclusion Criteria:
1. Severe corneal diseases or prior corneal surgery
2. Active, significant external ocular or eyelid disease
3. History of lens abnormalities including posterior polar cataract and zonular weakness precluding standard non-complex cataract surgery
4. Retinal or posterior segment disease
5. Advanced glaucoma, white or advanced cataract (precluding adequate examination of the posterior pole)
6. Anatomic conditions that prevent placement of the femtosecond laser docking ring
7. Corneal opacity that will interfere with the laser beam (hazy cornea)
8. Presence of blood or materials in the anterior chamber
9. Hypotony, advanced glaucoma, or presence of cornea implant
10. Poor dilating pupil such that the iris is not peripheral to the intended diameter for the capsulotomy
11. Condition which would cause inadequate clearance between the intended capsulotomy depth and the corneal endothelium
12. Any contraindication to cataract or kerato-refractive surgery
13. Contact lens wearers must discontinue the use of contacts for an appropriate period of time to ensure that their corneas are stable before screening measurements are performed. For rigid gas permeable (RGP) lenses, it is at least 2-4 weeks before accurate imaging measurements can be performed. Study doctor will assess patient findings and determine how long RGP lens wear must be discontinued prior to surgery. For soft contact lenses, it is at least 3 days prior to study measurements.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
99 Years
Study:
NCT02561104
Study Brief:
Protocol Section:
NCT02561104