Refractive Error
Conditions
Brief summary
Prospective, multi-center, non-interventional, randomized, comparative clinical study to identify an optimal refractive technique that provides maximum plus refractive endpoint for best corrected distance visual acuity (BCDVA).
Interventions
DEVICERefractive Technique (MR #1)
Fogging method that employs fogging lens to ensure there is sufficient visual defocus to induce blur.
DEVICERefractive Technique (MR #2)
Duochrome method that employs the chromatic aberration of the eye, with the shorter wavelengths (green) focused in front of the longer (red) wavelengths
Sponsors
Johnson & Johnson Surgical Vision, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Participant in PCOL-102-AHSF who were bilaterally implanted with TECNIS IOL, Models C1V000, C2V000 or ICB00 and have completed and are at least 30 days postoperative from their second eye surgery; 2. At least one implanted eye with clear ocular media; 3. Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in Australia and New Zealand; 4. Availability, willingness and sufficient cognitive awareness to comply with examination procedures.
Exclusion criteria
1. Best-corrected distance visual acuity (BCDVA) worse than 0.66 decimal (6/9 or 20/30 Snellen); 2. Subjects with ongoing adverse events that might impact outcomes during the study visit as determined by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference between two manifest refractive techniques on outcome variable MRSE | Day 0 | Refractive technique 1 will use a plus lens fogging technique and refractive technique 2 will use the Duochrome technique to achieve maximum plus refraction for best-corrected visual acuity (BCDVA). |
| Difference between two manifest refractive techniques on visual acuity | Day 0 | Refractive technique 1 will use a plus lens fogging technique and refractive technique 2 will use the Duochrome technique to achieve maximum plus refraction for best-corrected visual acuity (BCDVA). |
Countries
Australia
Outcome results
None listed