An observational study in Measurement of Refractive Error, sponsored by Johnson & Johnson Surgical Vision, Inc.. Completed at 1 site in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2025-07-23.
Sponsored by Johnson & Johnson Surgical Vision, Inc. · Observational
Prospective, single-site, non-interventional, technician masked, randomized (instrument and examiner testing sequences), controlled, bilateral, parallel-group study.
Johnson & Johnson Surgical Vision, Inc. is the lead sponsor of 36 studies on the registry; 1 is open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 13 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects 40 years of age or older who have been bilaterally implanted with either the TECNIS® Eyhance™ IOL (model ICB00, GIB00 or DIB00) or the TECNIS® Monofocal 1-Piece IOL (model ZCB00 or DCB00).
Inclusion Criteria following Screening
The subject must:
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:
In the study eye, meet the following criteria with regard to the non-vertex-corrected (i.e., spectacleplane) distance subjective refraction:
Exclusion Criteria following Screening
The subject must not:
Be currently participating in or have participated in any other clinical trial within 30 days prior to enrollment. Exclusion Criteria at Baseline Evaluation
The subject must not:
* 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
Diagnostic Test: Refractive 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
Refractive 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
Time frame: Two study visits, 1 to 14 calendar days apart. Study duration approximately 6 months.
Plan to share: Yes — Johnson \& Johnson Medical Devices Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA project site at http://yoda.yale.edu.
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Johnson & Johnson Surgical Vision, Inc.