Clinical trial NCT06767319: Prospective, Multi-center, Non-interventional, Open Label, Randomized (Depth of Focus Testing Sequences), Clinical Study
Official title: Comparison of Depth of Focus Testing Methods
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depth of Focus
Lead sponsor: Johnson & Johnson Surgical Vision, Inc.
Sponsor class: INDUSTRY
First posted: 2025-01-09
Enrollment: 79
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: As only one eye per subject will be enrolled in the study based on the eligibility criteria, up to 115 subjects will be enrolled to obtain data on approximately 80 subjects to account for approximately 30% screen failure rate.

Brief summary: The purpose of this clinical study is to evaluate the difference in depth of focus measured with two methods in patients implanted with either TECNIS 1-piece Monofocal IOL or TECNIS Eyhance IOL:

1. Trial lens method
2. Chart testing at appropriate focal distances (or viewing distances)


Eligibility criteria: Study Eye Inclusion Criteria:

1. Patients unilaterally or bilaterally implanted with a TECNIS non-toric/toric monofocal or TECNIS non-toric/toric Eyhance IOL;
2. Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws in U.S.;
3. Availability, willingness, and sufficient cognitive awareness to comply with examination procedures.
4. Adults (Minimum 22 years of age or older at the time of participation in the study);

Study Eye Exclusion Criteria

1. Patients within 30 days postoperative from surgery;
2. BCDVA worse than 20/32;
3. Posterior capsular opacification or other medical findings affecting best-corrected distance visual acuity (BCDVA) in the opinion of the investigator;
4. Clinically significant ocular surface disease that would affect study measurements based on investigator medical opinion;
5. Prior corneal refractive surgery (SMILE, LASIK, LASEK, RK, PRK, etc.);
6. Known ocular disease or pathology that, in the opinion of the investigator may affect visual acuity (macular degeneration, cystoid macular edema, diabetic retinopathy, glaucoma, retinal detachment etc.);
7. Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an employee (including partner, child, parent, grandparent, grandchild or sibling of the employee or their spouse) of the clinical site.

Primary outcomes:
measure: The difference in diopters of depth of focus range achieving a threshold of 0.20 logMAR between Trial lens vs. Chart testing method per pre-study IOL group.
timeFrame: One day Visit study
Secondary outcomes:
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Empire Eye & Laser Center
state: California
city: Sioux City
country: United States
facility: Jones Eye Center
state: Iowa
city: Brecksville
country: United States
facility: Cleveland Eye Clinic
state: Ohio
city: San Antonio
country: United States
facility: Parkhurst NuVision
state: Texas
Study officials:
References: