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

ArmDescriptionAssigned 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.
  • Diagnostic Test: OCT 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.
    Other names:
    • Basic Science
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

Empire Eye & Laser Center
Bakersfield, California 93309
Contact:
Daniel Chang
661-325-3937

Jones Eye Center
Sioux City, Iowa 51104
Contact:
Jason Jones
712-239-3937

More Details

Status
Recruiting
Sponsor
Johnson & Johnson Surgical Vision, Inc.

Study Contact

Siddhesh Raorane
904-539-7205
SRaorane@ITS.JNJ.com

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.