Odyssey Evaluation in Post LASIK Patients

Study Evaluating Visual Outcomes in Post-Myopic LASIK Patients After Implantation of the Odyssey Intraocular Lens

Odyssey Evaluation in Post LASIK Patients (NCT07260695) is a Phase 4 interventional studying Cataract, sponsored by Center For Sight. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 30 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: Subjects MUST fulfill the following conditions to qualify for enrollment into the trial 1. Age: 50 years and older. 2. Gender: Males and Females. 3. Bilateral cataracts 4. Bilateral implantation of Odyssey IOLs (toric and non-toric) 5. Scheduled to undergo standard cataract surgery in both eyes, within 1 to 30 days between surgeries. 6. Willing and able to provide written willing to sign a consent form for participation in the study. 7. Willing and able to comply with scheduled visits and study examination procedures. 8. Postoperative best corrected visual acuity of 0.2 logMAR (20/32 Snellen) or better in each eye. Who Should NOT Join This Trial: Subjects with ANY of the following conditions on the eligibility exam may NOT be enrolled into the trial. 1. 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. 2. Uncontrolled diabetes. 3. Use of any systemic or topical drug known to interfere with visual performance. 4. Any concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis. 5. Clinically significant corneal dystrophy. 6. Contact lens use during the active treatment portion of the trial. 7. Irregular astigmatism. 8. Corneal irregularities potentially affecting visual acuity (i.e., keratoconus, corneal opacities 9. History of chronic intraocular inflammation. 10. History of retinal detachment. 11. Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules. 12. Previous intraocular surgery. 13. Previous keratoplasty 14. Previous refractive surgery other than myopic LASIK or PRK (i.e., radial keratotomy, hyperopic LASIK, etc) 15. Severe dry eye. 16. Pupil abnormalities. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: Subjects MUST fulfill the following conditions to qualify for enrollment into the trial 1. Age: 50 years and older. 2. Gender: Males and Females. 3. Bilateral cataracts 4. Bilateral implantation of Odyssey IOLs (toric and non-toric) 5. Scheduled to undergo standard cataract surgery in both eyes, within 1 to 30 days between surgeries. 6. Willing and able to provide written informed consent for participation in the study. 7. Willing and able to comply with scheduled visits and study examination procedures. 8. Postoperative best corrected visual acuity of 0.2 logMAR (20/32 Snellen) or better in each eye. Exclusion Criteria: Subjects with ANY of the following conditions on the eligibility exam may NOT be enrolled into the trial. 1. 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. 2. Uncontrolled diabetes. 3. Use of any systemic or topical drug known to interfere with visual performance. 4. Any concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis. 5. Clinically significant corneal dystrophy. 6. Contact lens use during the active treatment portion of the trial. 7. Irregular astigmatism. 8. Corneal irregularities potentially affecting visual acuity (i.e., keratoconus, corneal opacities 9. History of chronic intraocular inflammation. 10. History of retinal detachment. 11. Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules. 12. Previous intraocular surgery. 13. Previous keratoplasty 14. Previous refractive surgery other than myopic LASIK or PRK (i.e., radial keratotomy, hyperopic LASIK, etc) 15. Severe dry eye. 16. Pupil abnormalities. 17. 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). 18. Any clinically significant, serious, or severe medical or psychiatric condition that may interfere with the interpretation of study results. 19. 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. 20. Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.) 21. 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.

Treatments Being Tested

DEVICE

Odyssey intraocular lens

The Odyssey intraocular lens is intended to be implanted at the time of cataract surgery to replace the natural lens.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Center For Sight

Venice, Florida, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07260695), the sponsor (Center For Sight), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07260695 clinical trial studying?

Who can participate in NCT07260695?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07260695?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07260695. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07260695. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.