CataractPhase 4NCT07260695
Odyssey Evaluation in Post LASIK Patients
A Phase 4 study testing Odyssey intraocular lens in people with Cataract, run by Center For Sight at 1 site in United States.
Trial summary
This prospective study evaluates the visual and refractive outcomes of the TECNIS Odyssey intraocular lens (IOL) implanted in patients with a history of myopic LASIK. Given the unique optical challenges of post-LASIK eyes, including altered corneal curvature and higher-order aberrations, the study aims to assess the… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Odyssey intraocular lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2025to 18 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects MUST fulfill the following conditions to qualify for enrollment into the trial
- Age: 50 years and older.
- Gender: Males and Females.
- Bilateral cataracts
- Bilateral implantation of Odyssey IOLs (toric and non-toric)
- Scheduled to undergo standard cataract surgery in both eyes, within 1 to 30 days between surgeries.
Show all 9Show fewer
- Willing and able to provide written informed consent for participation in the study.
- Willing and able to comply with scheduled visits and study examination procedures.
- Postoperative best corrected visual acuity of 0.2 logMAR (20/32 Snellen) or better in each eye.
Who cannot join
- Subjects with ANY of the following conditions on the eligibility exam may NOT be enrolled into the trial.
- Established ocular pathology, including: glaucoma (except glaucoma suspects), uveitis, and clinically-significant retinal pathology affecting the macula (with visual acuity worse than 20/25) and/or any other ocular findings that may, in the opinion of the investigator, affect vision.
- Uncontrolled diabetes.
- Use of any systemic or topical drug known to interfere with visual performance.
- Any concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis.
- Clinically significant corneal dystrophy.
Show all 23Show fewer
- Contact lens use during the active treatment portion of the trial.
- Irregular astigmatism.
- Corneal irregularities potentially affecting visual acuity (i.e., keratoconus, corneal opacities
- History of chronic intraocular inflammation.
- History of retinal detachment.
- Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules.
- Previous intraocular surgery.
- Previous keratoplasty
- Previous refractive surgery other than myopic LASIK or PRK (i.e., radial keratotomy, hyperopic LASIK, etc)
- Severe dry eye.
- Pupil abnormalities.
- Subject who may reasonably be expected to require a secondary surgical intervention at any time during the study (other than YAG capsulotomy, i.e., LASIK).
- Any clinically significant, serious, or severe medical or psychiatric condition that may interfere with the interpretation of study results.
- Participation in (or current participation) any ophthalmic investigational drug or ophthalmic device trial within the previous 30 days prior to the start date of this trial.
- Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.)
- Abnormal iris
- The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates the patient is unsuitable for the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study Evaluating Visual Outcomes in Post-Myopic LASIK Patients After Implantation of the Odyssey Intraocular Lens
This prospective study evaluates the visual and refractive outcomes of the TECNIS Odyssey intraocular lens (IOL) implanted in patients with a history of myopic LASIK. Given the unique optical challenges of post-LASIK eyes, including altered corneal curvature and higher-order aberrations, the study aims to assess the IOL's performance in terms of distance, intermediate, and near vision, and patient satisfaction. Its design features may offer favorable outcomes in these patients.
- Conditions
- Cataract
- Being tested
- Odyssey intraocular lens
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Odyssey intraocular lensDevice
The Odyssey intraocular lens is intended to be implanted at the time of cataract surgery to replace the natural lens.
| Study group | Role | What they receive |
|---|---|---|
| Odyssey IOL | Other | Not described Receives: Device: Odyssey intraocular lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binocular defocus curve
The defocus curve assesses a patient's visual performance at various distances by introducing different levels of lens defocus (measured in diopters) and recording the corresponding visual acuity. It provides a comprehensive evaluation of the range of clear vision (distance, intermediate, and near) offered by an intraocular lens.
Measured: 3 months postoperatively
Secondary outcomes (2)
Patient satisfaction
Percentage of patients who reported being completely, mostly, moderately, a little or not at all satisfied with overall vision
Measured: 3 months postoperatively
Spectacle independence at near.
Percentage of patients who reported wearing glasses none of the time or a little of the time for near activities (16 inches/40 cm).
Measured: 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start18 Aug 2025
- Primary completion18 Dec 2026 (estimated)
- Study completion18 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center For Sight
- Sponsor type
- University, hospital or other
- Collaborators
- Sengi Clinical
- Responsible party
- Sponsor
- Investigators
- Joaquin K De Rojas, MD, Principal investigator, Center For Sight
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07260695
- Sponsor's protocol ID
- CFS 25-001
- Status last verified
- Oct 2026
- First submitted
- 22 Aug 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- 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 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Evaluating Visual Outcomes in Post-Myopic LASIK Patients After Implantation of the Odyssey Intraocular Lens
- ClinicalTrials.gov ID
- NCT07260695
- Acronym / sponsor ID
- CFS 25-001
- Conditions
- Cataract
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Center For SightUniversity, hospital or other
- Collaborators
- Sengi Clinical
- Study start
- 18 Aug 2025 (actual)
- Primary completion
- 18 Dec 2026 (estimated)
- Study completion
- 18 Dec 2026 (estimated)
- First posted
- 3 Dec 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 prospective study evaluates the visual and refractive outcomes of the TECNIS Odyssey intraocular lens (IOL) implanted in patients with a history of myopic LASIK. Given the unique optical challenges of post-LASIK eyes, including altered corneal curvature and higher-order aberrations, the study aims to assess the IOL's performance in terms of distance, intermediate, and near vision, and patient satisfaction. Its design features may offer favorable outcomes in these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Odyssey IOL | Other | Device: Odyssey intraocular lens |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects MUST fulfill the following conditions to qualify for enrollment into the trial
- Age: 50 years and older.
- Gender: Males and Females.
- Bilateral cataracts
- Bilateral implantation of Odyssey IOLs (toric and non-toric)
Key exclusion criteria (23 listed)
- Subjects with ANY of the following conditions on the eligibility exam may NOT be enrolled into the trial.
- Established ocular pathology, including: glaucoma (except glaucoma suspects), uveitis, and clinically-significant retinal pathology affecting the macula (with visual acuity worse than 20/25) and/or any other ocular findings that may, in the opinion of the investigator, affect vision.
- Uncontrolled diabetes.
- Use of any systemic or topical drug known to interfere with visual performance.
- Any concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis.
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 intraocular lensThe Odyssey intraocular lens is intended to be implanted at the time of cataract surgery to replace the natural lens. | Device | Odyssey IOL |
Primary outcome
Binocular defocus curve
Time frame: 3 months postoperatively
The defocus curve assesses a patient's visual performance at various distances by introducing different levels of lens defocus (measured in diopters) and recording the corresponding visual acuity. It provides a comprehensive evaluation of the range of clear vision (distance, intermediate, and near) offered by an intraocular lens.
2 secondary outcomes
Patient satisfaction
Time frame: 3 months postoperatively
Spectacle independence at near.
Time frame: 3 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Cataract
RecruitingPhase 4
Arcuate Incisions With Light Adjustable Lens for Astigmatism Correction in Lens Surgery
Astigmatism
Recruiting
Clinical Evaluation of a Novel Trifocal IOL
Aphakia, Cataract
RecruitingObservational study
Intraoperative OCT Guidance of Intraocular Surgery II
Macular Holes, Epiretinal Membrane
Not yet recruitingObservational study
Postoperative Outcome Verification of Discrepant Toric IOL Calculator Recommendations After Cataract Surgery
Cataract
Not yet recruitingObservational study
Study on Eye-Brain Cross-Organ Mapping and Systemic Disease Association Based on Multimodal Big Data
Cataract, Vitreous Hemorrhage
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.
Joaquin K De Rojas, MD principal investigator
Center For Sight
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Odyssey intraocular lens in people with Cataract, run by Center For Sight 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 9 inclusion and 23 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: under way, not looking for participants, as of the sponsor's last update on 26 Oct 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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 defocus curve (time frame: 3 months postoperatively). 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 26 Oct 2026.