RLE Outcomes With Bilateral Implantation of Odyssey IOLs

NCT ID: NCT06979557

Last Updated: 2025-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-21

Study Completion Date

2026-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Refractive Lens Exchange

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Odyssey IOL

Bilateral Implantation with the Odyssey IOL

Odyssey IOL

Intervention Type DEVICE

Bilateral implantation with the Odyssey IOL

Interventions

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Odyssey IOL

Bilateral implantation with the Odyssey IOL

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sengi

INDUSTRY

Sponsor Role collaborator

Mann Eye Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Phillip Brunson, OD

Role: PRINCIPAL_INVESTIGATOR

Mann Eye Institute

Locations

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Mann Eye Institute

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Melissa Hamann Wright

Role: CONTACT

832-368-0117

Facility Contacts

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Melissa Hamann Wright

Role: primary

713-580-2500 ext. 2389

Other Identifiers

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PB-25-01

Identifier Type: -

Identifier Source: org_study_id

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