Recruiting

TECNIS Odyssey

Sponsor:

Center For Sight

Code:

NCT07260695

Conditions

Cataract

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Odyssey intraocular lens

Study Details

Brief 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 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

Study ID

NCT07260695

Start date

Aug 18, 2025

Status verified date

Dec, 2025

Completion date

Aug 18, 2026

Anticipated

Primary completion date

Aug 18, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Odyssey IOL

Interventions

Odyssey intraocular lens

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

Primary outcome measure

  • Binocular defocus curve [ Time Frame: 3 months postoperatively ]

Central Contacts and Locations

Central contacts

Helga P Sandoval

8438813937hps@cepmd.com

Locations

Center For Sight

Recruiting

Venice, Florida, United States, 34285

Contacts

More Information

Sponsor

Center For Sight

Last update posted

Dec 3, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Center For Sight on 2025-12-03.