Measuring intraocular lens tilt and decentration with OCT

Objective Assessment of Intraocular Lens Tilt and Decentration

This study tests an OCT image-analysis method to measure tilt and off-center position of TECNIS non-toric intraocular lenses in adults at least three months after implantation.

Quick facts

• Study type: Observational
• Enrollment: 80 (estimated)
• Ages: 22 Years and up
• Sex: All
• Sponsor: Johnson & Johnson Surgical Vision, Inc. (Industry-sponsored)
• Locations: 2 sites (Bakersfield, California and 1 other locations)
• Trial ID: NCT07324200 on ClinicalTrials.gov

What this trial studies

This is a prospective, multi-center, non-interventional, open-label randomized clinical study using Optical Coherence Tomography (OCT) imaging to analyze intraocular lens (IOL) position. The primary objective is to determine the repeatability and reproducibility of an OCT-based image-analysis method for quantifying IOL tilt and decentration in patients with unilateral or bilateral TECNIS refractive or diffractive non-toric IOLs. Participants will undergo standardized OCT imaging sessions with repeated scans and image analysis across operators and sites to measure variability. Key eligibility requirements include age 22 or older, at least three months postoperative in the study eye, and absence of ocular conditions that would impair fixation or imaging.

Who should consider this trial

Good fit: Adults aged 22 or older who received a non-toric TECNIS refractive or diffractive IOL in one or both eyes and are at least three months post‑implantation, able to fixate for OCT imaging, are ideal candidates.

Not a fit: Patients with toric IOLs, recent additional corneal or intraocular surgery, or ocular comorbidities that impair fixation or imaging (for example macular disease, corneal opacities, or advanced glaucoma) are unlikely to benefit from this imaging validation.

Why it matters

Potential benefit: If successful, the method could provide clinicians a reliable, repeatable OCT-based measurement to detect and quantify IOL misalignment and guide management decisions.

How similar studies have performed: OCT-based measurements of IOL tilt and decentration have been reported in prior research and show promise, but a dedicated repeatability and reproducibility validation for this specific OCT image-analysis method in TECNIS non-toric lenses is relatively novel.

Eligibility criteria

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.

Where this trial is running

Bakersfield, California and 1 other locations

• Empire Eye & Laser Center — Bakersfield, California, United States (Recruiting)
• Jones Eye Center — Sioux City, Iowa, United States (Recruiting)

Study contacts

• Study coordinator: Siddhesh Raorane

Conditions Tilt and Decentration