Tilt and Decentration
Conditions
Brief summary
Prospective, multi-center, non-interventional, open label, randomized clinical study.
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.
Interventions
DIAGNOSTIC_TESTOCT Imaging Test
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 or diffractive non-toric IOL models.
Sponsors
Johnson & Johnson Surgical Vision, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Magnitude and Direction of IOL decentration and; Magnitude and Direction of IOL tilt. | One study visit | The primary endpoints for this study will be: * Magnitude of IOL decentration relative to the visual axis through OCT (IOL Master 700) image analysis. * Direction of IOL decentration relative to the visual axis through OCT (IOL Master 700) image analysis. * Magnitude of IOL tilt relative to the visual axis through OCT (IOL Master 700) image analysis. * Direction of IOL tilt relative to the visual axis through OCT (IOL Master 700) image analysis. |
Countries
United States
Contacts
STUDY_DIRECTORSurgical Vision Inc. Johnson and Johnson
Sponsor GmbH
Outcome results
None listed