RecruitingNot Applicable

Objective Assessment of Intraocular Lens Tilt and Decentration

United States80 participantsStarted 2026-03-03

Plain-language summary

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

Age range22 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

Magnitude and Direction of IOL decentration and; Magnitude and Direction of IOL tilt.

Timeframe: One study visit

NCT IDNCT07324200

SponsorJohnson & Johnson Surgical Vision, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-06-26

Siddhesh Raorane

Who can participate

Age range22 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.