RLE Outcomes With Bilateral Implantation of Odyssey IOLs

Ambispective Analysis of Patient Reported Outcomes and Visual Acuity in Patients Undergoing a Refractive Lens Exchange With Bilateral Implantation Odyssey Intraocular Lenses

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06979557

Enrollment

Registered

2025-05-20

Start date

2025-07-21

Completion date

2026-01-01

Last updated

2026-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractive Lens Exchange

Brief 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.

Interventions

DEVICEOdyssey IOL

Bilateral implantation with the Odyssey IOL

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Binocular Photopic Visual Acuity	2 months posoperatively	Measured at distance (6m), intermediate at 66cm, and near visual acuity at 40cm and 33cm.
Monocular Photopic Visual Acuity	2 months posoperatively	Measured at distance (6m), intermediate at 66cm, and near visual acuity at 40cm and 33cm.
Monocular Defocus Curve (right eye only)	2 months posoperatively	—
Binocular Defocus Curve	2 months posoperatively	—

Secondary

Measure	Time frame	Description
Assessment of IntraOcular Lens Implant Symptoms (AIOLIS) Questionnaire	2 months posoperatively	The AIOLIS has 37 questions about symptoms, perceptions of general vision, and frequency of wearing glasses or contact lenses. Lower scores for the symptom questions indicate lower frequency and both of visual disturbances.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORPhillip Brunson, OD

Mann Eye Institute

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026