CompletedNot Applicable

RLE Outcomes With Bilateral Implantation of Odyssey IOLs

United States40 participantsStarted 2025-07-21

Plain-language summary

This study is a single center, ambispective study of visual outcomes after successful bilateral implantation of the Odyssey IOL. Subjects will be assessed at least 2 months postoperatively at a single visit. Clinical evaluations will include administration of the AIOLIS questionnaire, as well as measurement of visual acuities at distance, intermediate, and near, monocular (right eye) and binocular defocus curve, and refractive outcomes.

Who can participate

Age range40 Years

SexALL

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Inclusion Criteria: * Participants will include 40 patients aged 40 years and older who have a measurable Potential Acuity Meter (PAM) of 20/20 electing to undergo bilateral refractive lensectomy surgery with IOL implantation. Exclusion Criteria: * Patients with significant ocular comorbidities (e.g., macular degeneration, glaucoma) or prior intraocular surgery will be excluded.

What they're measuring

Binocular Photopic Visual Acuity

Timeframe: 2 months posoperatively

Monocular Photopic Visual Acuity

Timeframe: 2 months posoperatively

Monocular Defocus Curve (right eye only)

Timeframe: 2 months posoperatively

Binocular Defocus Curve

Timeframe: 2 months posoperatively

Trial details

NCT IDNCT06979557

SponsorMann Eye Institute

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-01-01

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