Objective Assessment of Intraocular Lens Tilt and Decentration

Conditions

• Tilt and Decentration

Eligibility Criteria

Sex

ALL

Age

22 Years - N/A

Healthy Volunteers

Accepted

Interventions

• OCT Imaging Test — DIAGNOSTIC_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.

Study Details

Prospective, multi-center, non-interventional, open label, randomized clinical study.

Key Dates

Start date

Mar 3, 2026

Status verified

May 2026

Primary completion

Jun 26, 2026

Completion

Jun 26, 2026

Study Design

Enrollment

80 participants (estimated)

Arms

• Arm: 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.
• Arm: 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.

Primary Outcome Measure

Magnitude and Direction of IOL decentration and; Magnitude and Direction of IOL tilt. [ Time Frame: One study visit ]

Central Contacts

• Siddhesh Raorane
  904-539-7205
  [email protected]
• Kristen Leraas
  [email protected]

Locations (2)

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