Refractive Lens ExchangeNCT06979557
RLE Outcomes With Bilateral Implantation of Odyssey IOLs
An observational study of Refractive Lens Exchange, 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 implantation of the Odyssey IOL. Subjects will be assessed at least 2 months postoperatively at a single visit. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Refractive Lens Exchange
- What is being tested?
- Odyssey IOL
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2025to 1 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible test subjects will be aged 40 years and older who underwent bilateral implantation with the Odyssey IOL.
Who may be able to join
- 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.
Who cannot join
- Patients with significant ocular comorbidities (e.g., macular degeneration, glaucoma) or prior intraocular surgery will be excluded.
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 Undergoing a Refractive Lens Exchange With Bilateral Implantation Odyssey Intraocular Lenses
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.
- Conditions
- Refractive Lens Exchange
- Being tested
- Odyssey IOL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Odyssey IOLDevice
Bilateral implantation with the Odyssey IOL
| Study group | Role | What they receive |
|---|---|---|
| Odyssey IOL | Bilateral Implantation with the Odyssey IOL Receives: Device: Odyssey IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binocular Photopic Visual Acuity
Measured at distance (6m), intermediate at 66cm, and near visual acuity at 40cm and 33cm.
Measured: 2 months posoperatively
Monocular Photopic Visual Acuity
Measured at distance (6m), intermediate at 66cm, and near visual acuity at 40cm and 33cm.
Measured: 2 months posoperatively
Monocular Defocus Curve (right eye only)
Measured: 2 months posoperatively
Binocular Defocus Curve
Measured: 2 months posoperatively
Secondary outcomes (1)
Assessment of IntraOcular Lens Implant Symptoms (AIOLIS) Questionnaire
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.
Measured: 2 months posoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start21 Jul 2025
- Primary completion1 Jan 2026
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractive Lens ExchangeStudies 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
- Prospective
- 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
- NCT06979557
- Sponsor's protocol ID
- PB-25-01
- Status last verified
- Feb 2026
- First submitted
- 13 May 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- 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 27 Feb 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 Undergoing a Refractive Lens Exchange With Bilateral Implantation Odyssey Intraocular Lenses
- ClinicalTrials.gov ID
- NCT06979557
- Acronym / sponsor ID
- PB-25-01
- Conditions
- Refractive Lens Exchange
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mann Eye InstituteUniversity, hospital or other
- Collaborators
- Sengi
- Study start
- 21 Jul 2025 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 20 May 2025 (actual)
- Results
- Not posted in the source record
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Odyssey IOL | – | Device: Odyssey IOLBilateral Implantation with the Odyssey IOL |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible test subjects will be aged 40 years and older who underwent bilateral implantation with the Odyssey IOL.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients with significant ocular comorbidities (e.g., macular degeneration, glaucoma) or prior intraocular surgery will be excluded.
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 |
|---|---|---|
| Odyssey IOLBilateral implantation with the Odyssey IOL | Device | Odyssey IOL |
Primary outcome
Binocular Photopic Visual Acuity
Time frame: 2 months posoperatively
Measured at distance (6m), intermediate at 66cm, and near visual acuity at 40cm and 33cm.
Monocular Photopic Visual Acuity
Time frame: 2 months posoperatively
Measured at distance (6m), intermediate at 66cm, and near visual acuity at 40cm and 33cm.
Monocular Defocus Curve (right eye only)
Time frame: 2 months posoperatively
Binocular Defocus Curve
Time frame: 2 months posoperatively
1 secondary outcome
Assessment of IntraOcular Lens Implant Symptoms (AIOLIS) Questionnaire
Time frame: 2 months posoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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 Refractive Lens Exchange, 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 1 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 27 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Binocular Photopic Visual Acuity (time frame: 2 months posoperatively). 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 27 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.