Clinical Outcomes With Bilateral Implantation of Odyssey IOLs
Ambispective Analysis of Patient Reported Outcomes and Visual Acuity in Patients With Bilateral Implantation of 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 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.
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 Sep 2024
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
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 9, 2024
CompletedFirst Posted
Study publicly available on registry
August 13, 2024
CompletedStudy Start
First participant enrolled
September 5, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 26, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 26, 2025
CompletedResults Posted
Study results publicly available
April 8, 2026
CompletedApril 8, 2026
March 1, 2026
7 months
August 9, 2024
February 25, 2026
March 19, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
Visual Acuity at Distance (6m) logMAR
Photopic and mesopic, binocular and monocular, and uncorrected and distance corrected
3 months postoperative
Visual Acuity at Intermediate (66cm) logMAR
Photopic and mesopic, binocular and monocular, and uncorrected and distance corrected
3 months postoperative
Visual Acuity at Near (40cm) logMAR
Photopic and mesopic, binocular and monocular, and uncorrected and distance corrected
3 months postoperative
Visual Acuity at Near (33cm) logMAR
Photopic and mesopic, binocular and monocular, and uncorrected and distance corrected
3 months postoperative
Secondary Outcomes (1)
Assessment of IntraOcular Lens Implant Symptoms (AIOLIS) Questionniare
3 months postoperative
Study Arms (1)
TECNIS Odyssey IOL
Interventions
Eligibility Criteria
Eligible test subjects will be aged 50 years and older who underwent bilateral cataract surgery with Odyssey IOL implantation.
You may qualify if:
- Patients aged 50 years and older who underwent bilateral cataract surgery with Odyssey IOL implantation.
You may not qualify if:
- Significant ocular comorbidities (e.g., macular degeneration, glaucoma).
- \< 2 weeks post YAG capsulotomy.
- Best corrected distance visual acuity worse than 20/25.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mann Eye Institutelead
- Sengicollaborator
Study Sites (1)
Mann Eye Institute
Houston, Texas, 76134-2099, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Phillip Brunson
- Organization
- Mann Eye Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Phillip Brunson, OD
Mann Eye Institute
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2024
First Posted
August 13, 2024
Study Start
September 5, 2024
Primary Completion
March 26, 2025
Study Completion
March 26, 2025
Last Updated
April 8, 2026
Results First Posted
April 8, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share