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OpenTrials
Completed

NCT Number: NCT06550375

Clinical Outcomes With Bilateral Implantation of Odyssey IOLs

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mann Eye Institute

Houston, Texas, 76134-2099, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TECNIS Odyssey IOL

Device

Implantation with the TECNIS Odyssey IOL

Primary outcomes

  1. Visual Acuity at Distance (6m) logMAR

    Time frame: 3 months postoperative

    Photopic and mesopic, binocular and monocular, and uncorrected and distance corrected

  2. Visual Acuity at Intermediate (66cm) logMAR

    Time frame: 3 months postoperative

    Photopic and mesopic, binocular and monocular, and uncorrected and distance corrected

  3. Visual Acuity at Near (40cm) logMAR

    Time frame: 3 months postoperative

    Photopic and mesopic, binocular and monocular, and uncorrected and distance corrected

  4. Visual Acuity at Near (33cm) logMAR

    Time frame: 3 months postoperative

    Photopic and mesopic, binocular and monocular, and uncorrected and distance corrected

Secondary outcomes

  1. Assessment of IntraOcular Lens Implant Symptoms (AIOLIS) Questionniare

    Time frame: 3 months postoperative

    The AIOLIS has 37 questions about symptoms, perceptions of general vision, and frequency of wearing glasses or contact lenses. Perceptions about general vision are asked on a 5 item scale (Poor, Fair, Good, Very good, Excellent). Poor is considered a worse outcome.

Sponsors and collaborators

Lead sponsor

Mann Eye Institute

Other

Collaborators

  • Sengi

Registry information

Official study title

Ambispective Analysis of Patient Reported Outcomes and Visual Acuity in Patients With Bilateral Implantation of Odyssey Intraocular Lenses

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 13, 2024
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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