Objective Assessment of Intraocular Lens Tilt and Decentration
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: OCT Imaging Test.
- Who it may be relevant to
- Registry conditions: Tilt and Decentration. Basic parameters: from 22 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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 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.
Primary outcome measures
- Magnitude and Direction of IOL decentration and; Magnitude and Direction of IOL tilt. [Time frame: One study visit]
Eligibility criteria
INCLUSION CRITERIA (ALL CRITERIA APPLY TO STUDY EYE)
- Read, understand, and sign the informed consent and HIPAA authorization forms, and receive a fully executed copy of the signed forms.
- Appear capable and willing to adhere to the clinical protocol instructions.
- Be 22 years of age or older at the time of screening.
- Have undergone unilateral or bilateral implantation with a desired non-toric TECNIS IOL design (e.g., refractive or diffractive).
- At least three months postoperative in the eligible eye.
EXCLUSION CRITERIA (ALL CRITERIA APPLY TO STUDY EYE)
- 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.
- Have any condition that may affect the eye's ability to fixate (e.g., amblyopia).
- Have a history of corneal or intraocular surgery other than cataract surgery.
- Using ocular or systemic medications known to interact with dilation drops.
- Have a history of allergic reactions to dilation drops.
- Have clinically significant pupil abnormalities (e.g., non-reactive, fixed, or abnormally shaped pupils).
- Has an intraocular pressure of ≥ 21mm Hg before mydriasis.
- Have a mydriatic pupil diameter of less than 6 mm.
- Have participated in a clinical trial within 7 days prior to study enrollment.
- 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.
- Currently pregnant or lactating.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 2 centers
- Empire Eye & Laser Center — Bakersfield
- Jones Eye Center — Sioux City
Identifiers
NCT: NCT07324200 · MDEV113OCTI