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OpenTrials
Completed

NCT Number: NCT06979557

RLE Outcomes With Bilateral Implantation of Odyssey IOLs

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.

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Key information

Conditions

Refractive Lens Exchange

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mann Eye Institute

Houston, Texas, 76134-2099, United States

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Odyssey IOL

Device

Bilateral implantation with the Odyssey IOL

Primary outcomes

  1. Binocular Photopic Visual Acuity

    Time frame: 2 months posoperatively

    Measured at distance (6m), intermediate at 66cm, and near visual acuity at 40cm and 33cm.

  2. Monocular Photopic Visual Acuity

    Time frame: 2 months posoperatively

    Measured at distance (6m), intermediate at 66cm, and near visual acuity at 40cm and 33cm.

  3. Monocular Defocus Curve (right eye only)

    Time frame: 2 months posoperatively

  4. Binocular Defocus Curve

    Time frame: 2 months posoperatively

Secondary outcomes

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

    Time frame: 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.

Other outcomes

  1. Percentage of patients within ± 0.5 D MRSE

    Time frame: 2 months posoperatively

    Manifest refraction spherical equivalent (MRSE)

  2. Percentage of eyes requiring additional corneal refractive procedures

    Time frame: 2 months postoperative

  3. Correlation between pupil size and defocus curve

    Time frame: 2 months postoperative

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 Undergoing a Refractive Lens Exchange With Bilateral Implantation Odyssey Intraocular Lenses

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 20, 2025
Registry last updated
Feb 27, 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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