Odyssey Evaluation in Post LASIK Patients

Center For Sight

Status and phase: Enrolling; Phase 4

Conditions: Cataract

Treatments: Device: Odyssey intraocular lens

Study type: Interventional

Funder types: Other

Identifiers

NCT07260695

CFS 25-001

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Odyssey IOL

Other group

Treatment:

Device: Odyssey intraocular lens