N/A
N=40
Clinical Outcomes With Bilateral Implantation of Odyssey IOLs
Cataract
Bottom Line
View on ClinicalTrials.gov: NCT06550375 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcome: Primary: Visual Acuity at Distance (6m) logMAR — 0.00; -0.02; 0.02; 0.00 logMAR
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- TECNIS Odyssey IOL (Device)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Mann Eye Institute
- Primary completion
- Mar 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Acuity at Distance (6m) logMAR |
0.00; -0.02; 0.02; 0.00; -0.07; -0.07 | — |
| PRIMARY Visual Acuity at Intermediate (66cm) logMAR |
0.06; 0.09; 0.12; 0.11; 0.03; 0.01 | — |
| PRIMARY Visual Acuity at Near (40cm) logMAR |
0.10; 0.07; 0.11; 0.09; 0.02; 0.02 | — |
| PRIMARY Visual Acuity at Near (33cm) logMAR |
0.04; 0.01; 0.06; 0.04; -0.02; -0.02 | — |
| SECONDARY Assessment of IntraOcular Lens Implant Symptoms (AIOLIS) Questionniare |
34; 40; 35; 31 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT06550375). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.