Clinical Outcomes With Bilateral Implantation of Odyssey IOLs

NCT ID: NCT06550375

Last Updated: 2025-05-11

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

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-05

Study Completion Date

2025-03-26

Brief Summary

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This study is a single center, ambispective study of visual outcomes after successful bilateral cataract surgery. Subjects will be assessed at least 3 months postoperatively at a single visit. Clinical evaluations will include administration of the AIOLIS and OSDI questionnaires, as well as measurement of visual acuities at distance, intermediate, and near.

Detailed Description

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Conditions

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Cataract

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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TECNIS Odyssey IOL

TECNIS Odyssey IOL

Intervention Type DEVICE

Implantation with the TECNIS Odyssey IOL

Interventions

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TECNIS Odyssey IOL

Implantation with the TECNIS Odyssey IOL

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

• Patients aged 50 years and older who underwent bilateral cataract surgery with Odyssey IOL implantation.

Exclusion Criteria

* Significant ocular comorbidities (e.g., macular degeneration, glaucoma).
* \< 2 weeks post YAG capsulotomy.
* Best corrected distance visual acuity worse than 20/25.
Minimum Eligible Age

50 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

Countries

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United States

Other Identifiers

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PB-24-01

Identifier Type: -

Identifier Source: org_study_id

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