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
1 other identifier
observational
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2025
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2025
CompletedFirst Posted
Study publicly available on registry
May 20, 2025
CompletedStudy Start
First participant enrolled
July 21, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2026
CompletedFebruary 27, 2026
February 1, 2026
5 months
May 13, 2025
February 25, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
Binocular Photopic Visual Acuity
Measured at distance (6m), intermediate at 66cm, and near visual acuity at 40cm and 33cm.
2 months posoperatively
Monocular Photopic Visual Acuity
Measured at distance (6m), intermediate at 66cm, and near visual acuity at 40cm and 33cm.
2 months posoperatively
Monocular Defocus Curve (right eye only)
2 months posoperatively
Binocular Defocus Curve
2 months posoperatively
Secondary Outcomes (1)
Assessment of IntraOcular Lens Implant Symptoms (AIOLIS) Questionnaire
2 months posoperatively
Other Outcomes (3)
Percentage of patients within ± 0.5 D MRSE
2 months posoperatively
Percentage of eyes requiring additional corneal refractive procedures
2 months postoperative
Correlation between pupil size and defocus curve
2 months postoperative
Study Arms (1)
Odyssey IOL
Bilateral Implantation with the Odyssey IOL
Interventions
Eligibility Criteria
Eligible test subjects will be aged 40 years and older who underwent bilateral implantation with the Odyssey IOL.
You may qualify if:
- 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.
You may not qualify if:
- Patients with significant ocular comorbidities (e.g., macular degeneration, glaucoma) or prior intraocular surgery will be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sengicollaborator
- Mann Eye Institutelead
Study Sites (1)
Mann Eye Institute
Houston, Texas, 76134-2099, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Phillip Brunson, OD
Mann Eye Institute
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2025
First Posted
May 20, 2025
Study Start
July 21, 2025
Primary Completion
January 1, 2026
Study Completion
January 1, 2026
Last Updated
February 27, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share