Objective Assessment of Intraocular Lens Tilt and Decentration
Purpose
Prospective, multi-center, non-interventional, open label, randomized clinical study.
Condition
- Tilt and Decentration
Eligibility
- Eligible Ages
- Over 22 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
(ALL CRITERIA APPLY TO STUDY EYE) 1. Read, understand, and sign the informed consent and HIPAA authorization forms, and receive a fully executed copy of the signed forms. 2. Appear capable and willing to adhere to the clinical protocol instructions. 3. Be 22 years of age or older at the time of screening. 4. Have undergone unilateral or bilateral implantation with a desired non-toric TECNIS IOL design (e.g., refractive or diffractive). 5. At least three months postoperative in the eligible eye.
Exclusion Criteria
(ALL CRITERIA APPLY TO STUDY EYE) 1. Any medical or ocular history, in the opinion of the investigator, that may impact study procedures such as ocular trauma, pseudoexfoliation syndrome, retinal pigment degeneration, macular pathology, glaucoma, retinal disease, corneal disease, or corneal opacities. 2. Have any condition that may affect the eye's ability to fixate (e.g., amblyopia). 3. Have a history of corneal or intraocular surgery other than cataract surgery. 4. Using ocular or systemic medications known to interact with dilation drops. 5. Have a history of allergic reactions to dilation drops. 6. Have clinically significant pupil abnormalities (e.g., non-reactive, fixed, or abnormally shaped pupils). 7. Has an intraocular pressure of ≥ 21mm Hg before mydriasis. 8. Have a mydriatic pupil diameter of less than 6 mm. 9. Have participated in a clinical trial within 7 days prior to study enrollment. 10. An employee (e.g., Investigator, Coordinator, or Technician) or immediate family member (including partner, child, parent, grandparent, grandchild, or sibling) of an employee of the clinical site or study sponsor. 11. Currently pregnant or lactating.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| TECNIS refractive non-toric IOL models | The primary objective of this study is to evaluate the repeatability and reproducibility (R&R) of a method based on Optical Coherence Tomography (OCT) image analysis for assessing IOL tilt and decentration in patients unilaterally or bilaterally implanted with TECNIS refractive non-toric IOL models. |
|
| TECNIS diffractive non-toric IOL models | The primary objective of this study is to evaluate the repeatability and reproducibility (R&R) of a method based on Optical Coherence Tomography (OCT) image analysis for assessing IOL tilt and decentration in patients unilaterally or bilaterally implanted with TECNIS diffractive non-toric IOL models. |
|
Recruiting Locations
Bakersfield, California 93309
Daniel Chang
661-325-3937
Sioux City, Iowa 51104
Jason Jones
712-239-3937
More Details
- Status
- Recruiting
- Sponsor
- Johnson & Johnson Surgical Vision, Inc.
Detailed Description
The objective of this study is to evaluate the repeatability and reproducibility (R&R) of a method based on Optical Coherence Tomography (OCT) image analysis for assessing IOL tilt and decentration in patients unilaterally or bilaterally implanted with TECNIS refractive or diffractive non-toric IOL models.