CataractNCT06550375
Clinical Outcomes With Bilateral Implantation of Odyssey IOLs
An observational study of Cataract, run by Mann Eye Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- TECNIS Odyssey IOL
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2024to 26 Mar 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Adult, Older adult
Study population: Eligible test subjects will be aged 50 years and older who underwent bilateral cataract surgery with Odyssey IOL implantation.
Who may be able to join
- Patients aged 50 years and older who underwent bilateral cataract surgery with Odyssey IOL implantation.
Who cannot join
- Significant ocular comorbidities (e.g., macular degeneration, glaucoma).
- < 2 weeks post YAG capsulotomy.
- Best corrected distance visual acuity worse than 20/25.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ambispective Analysis of Patient Reported Outcomes and Visual Acuity in Patients With Bilateral Implantation of Odyssey Intraocular Lenses
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.
- Conditions
- Cataract
- Being tested
- TECNIS Odyssey IOL
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TECNIS Odyssey IOLDevice
Implantation with the TECNIS Odyssey IOL
| Study group | Role | What they receive |
|---|---|---|
| TECNIS Odyssey IOL | Not described Receives: Device: TECNIS Odyssey IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity at Distance (6m) logMAR
Photopic and mesopic, binocular and monocular, and uncorrected and distance corrected
Measured: 3 months postoperative
Visual Acuity at Intermediate (66cm) logMAR
Photopic and mesopic, binocular and monocular, and uncorrected and distance corrected
Measured: 3 months postoperative
Visual Acuity at Near (40cm) logMAR
Photopic and mesopic, binocular and monocular, and uncorrected and distance corrected
Measured: 3 months postoperative
Visual Acuity at Near (33cm) logMAR
Photopic and mesopic, binocular and monocular, and uncorrected and distance corrected
Measured: 3 months postoperative
Secondary outcomes (1)
Assessment of IntraOcular Lens Implant Symptoms (AIOLIS) Questionniare
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.
Measured: 3 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start5 Sep 2024
- Primary completion26 Mar 2025
- Study completion26 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mann Eye Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Sengi
- Responsible party
- Sponsor
- Investigators
- Phillip Brunson, OD, Principal investigator, Mann Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06550375
- Sponsor's protocol ID
- PB-24-01
- Status last verified
- Mar 2026
- First submitted
- 9 Aug 2024
- Last updated
- 8 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambispective Analysis of Patient Reported Outcomes and Visual Acuity in Patients With Bilateral Implantation of Odyssey Intraocular Lenses
- ClinicalTrials.gov ID
- NCT06550375
- Acronym / sponsor ID
- PB-24-01
- Conditions
- Cataract
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mann Eye InstituteUniversity, hospital or other
- Collaborators
- Sengi
- Study start
- 5 Sep 2024 (actual)
- Primary completion
- 26 Mar 2025 (actual)
- Study completion
- 26 Mar 2025 (actual)
- First posted
- 13 Aug 2024 (actual)
- Results
- Posted 8 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TECNIS Odyssey IOL | – | Device: TECNIS Odyssey IOL |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Eligible test subjects will be aged 50 years and older who underwent bilateral cataract surgery with Odyssey IOL implantation.
Key inclusion criteria (1 listed)
- Patients aged 50 years and older who underwent bilateral cataract surgery with Odyssey IOL implantation.
Key exclusion criteria (3 listed)
- Significant ocular comorbidities (e.g., macular degeneration, glaucoma).
- < 2 weeks post YAG capsulotomy.
- Best corrected distance visual acuity worse than 20/25.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TECNIS Odyssey IOLImplantation with the TECNIS Odyssey IOL | Device | TECNIS Odyssey IOL |
Primary outcome
Visual Acuity at Distance (6m) logMAR
Time frame: 3 months postoperative
Photopic and mesopic, binocular and monocular, and uncorrected and distance corrected
Visual Acuity at Intermediate (66cm) logMAR
Time frame: 3 months postoperative
Photopic and mesopic, binocular and monocular, and uncorrected and distance corrected
Visual Acuity at Near (40cm) logMAR
Time frame: 3 months postoperative
Photopic and mesopic, binocular and monocular, and uncorrected and distance corrected
Visual Acuity at Near (33cm) logMAR
Time frame: 3 months postoperative
Photopic and mesopic, binocular and monocular, and uncorrected and distance corrected
1 secondary outcome
Assessment of IntraOcular Lens Implant Symptoms (AIOLIS) Questionniare
Time frame: 3 months postoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Cataract
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
Aphakia, Postcataract
Not yet recruiting
Effects of Oxygen Cage Support During Cataract Surgery
Cataract
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments
Light Adjustable Lens, Objective Depth of Focus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Phillip Brunson, OD principal investigator
Mann Eye Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract, run by Mann Eye Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Acuity at Distance (6m) logMAR (time frame: 3 months postoperative). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.