RLE Outcomes With Bilateral Implantation of Odyssey IOLs

Mann Eye Institute

Status: Enrolling

Conditions: Refractive Lens Exchange

Treatments: Device: Odyssey IOL

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06979557

PB-25-01

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

40 participants in 1 patient group

Odyssey IOL

Description:

Bilateral Implantation with the Odyssey IOL

Treatment:

Device: Odyssey IOL