Measurement of Refractive Error
Conditions
Brief summary
Prospective, single-site, non-interventional, technician masked, randomized (instrument and examiner testing sequences), controlled, bilateral, parallel-group study.
Interventions
DIAGNOSTIC_TESTRefractive Error
* Refractive error centrally (on-axis) and peripherally in both nasal and temporal visual fields * Ocular wavefront measured centrally (on-axis) and peripherally in both nasal and temporal visual fields
Sponsors
Johnson & Johnson Surgical Vision, Inc.
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
following Screening The subject must: 1. Read, understand, and sign the Statement of Informed Consent and HIPAA authorization and receive a fully executed copy of the form(s). 2. Appear able and willing to adhere to the instructions set forth in this clinical protocol. 3. Be 40 years of age or older at the time of enrollment. 4. Be pseudophakic in at least one eye, with that eye (hereafter referred to as the 'study eye') implanted with either the TECNIS Eyhance™ IOL (model ICB00, GIB00 or DIB00) or the TECNIS® Monofocal 1-Piece IOL (model ZCB00 or DCB00). 5. Have had IOL surgery for the study eye completed at least 3 months prior to enrollment, with enough time elapsed between surgery and enrollment such that the refraction has stabilized in that eye. Inclusion Criteria at Baseline Evaluation The subject must: 6. In the study eye, meet the following criteria with regard to the non-vertex-corrected (i.e., spectacleplane) distance subjective refraction: 1. Mean spherical equivalent must be between +2.00 and -2.00 DS (inclusive). 2. The magnitude of the cylinder must be 1.50 DC or less. 7. Have best-corrected visual acuity of at least 20/32 in the study eye.
Exclusion criteria
following Screening The subject must not: 1. Be pregnant. 2. Have uncontrolled diabetes by self-report. 3. Have a history of ocular trauma, systemic disease or medication use known to cause variability in refractive error. 4. Have had or have planned (within the study period) any ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, iridotomy, retinal laser photocoagulation, etc.) other than bilateral cataract surgery with IOL implantation and YAG laser capsulotomy. 5. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, scleral lenses, or hybrid lenses (e.g., SynergEyes, SoftPerm) within the past 3 months. 6. 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 or study Sponsor. 7. Be taking any ocular or systemic medications known to adversely affect vision or cause miosis, or that may otherwise compromise study endpoints. 8. Be currently participating in or have participated in any other clinical trial within 30 days prior to enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Refractive Error | Two study visits, 1 to 14 calendar days apart. Study duration approximately 6 months. | * Refractive error centrally (on-axis) and peripherally in both nasal and temporal visual fields * Ocular wavefront measured centrally (on-axis) and peripherally in both nasal and temporal visual fields |
Countries
United States
Outcome results
None listed