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Prospective, multi-center, non-interventional, open label, clinical study.
The objective is to evaluate two methods for assessing IOL tilt and decentration in patients who have been unilaterally or bilaterally implanted with a refractive or diffractive nontoric TECNIS IOL before participating into this study. The agreement will be assessed between the decentration measurements derived from retro-illuminated slit lamp image analysis and those obtained from the subjective slit lamp grading method.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IOL Decentration | The objective is to evaluate two methods for assessing IOL tilt and decentration in patients who have been unilaterally or bilaterally implanted with a refractive or diffractive non- toric TECNIS IOL before participating into this study. The agreement will be assessed between the decentration measurements derived from retro-illuminated slit lamp image analysis and those obtained from the subjective slit lamp grading method. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IOL Decentration Assessment | Diagnostic Test | This study assesses two methods to measure IOL decentration. Each subject will be evaluated in only one eye with both methods for assessing IOL decentration: (i) retro-illuminated slit lamp image analysis (objective slit lamp method) and (ii) subjective slit lamp grading method. There is no treatment or intervention on this study. |
| Measure | Description | Time Frame |
|---|---|---|
| IOL Decentration |
| 3 months |
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Inclusion:
All criteria apply to study eye.
The subject must:
Exclusion:
All criteria apply to study eye.
The subject must NOT:
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Participants eligible for the study must be 22 years of age or older and have received a refractive or diffractive nontoric TECNIS IOL in at least one eye. Additionally, they must be at least three months post-operative in the designated study eye. The Investigator should choose the eye without any clinically significant medical conditions that may interfere with the evaluation of IOL tilt and decentration using the testing methods specified in this study. If both eyes meet the eligibility criteria, the right eye will be designated as the study eye.
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| Name | Affiliation | Role |
|---|---|---|
| Surgical Vision Inc. Johnson and Johnson | Study Director | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Empire Eye & Laser Center | Bakersfield | California | 93309 | United States | ||
| Jones Eye Center |
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.
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| Sioux City |
| Iowa |
| 51104 |
| United States |