TECNIS Odyssey intraocular lens for people who had myopic LASIK

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

This will test whether the TECNIS Odyssey intraocular lens improves distance, intermediate, and near vision and patient satisfaction in people 50 and older who previously had myopic LASIK and now need cataract surgery.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: Center For Sight (Academic / other)
• Locations: 1 site (Venice, Florida)
• Trial ID: NCT07260695 on ClinicalTrials.gov

What this trial studies

This prospective, phase 4 study enrolls patients with prior myopic LASIK who are undergoing bilateral cataract surgery and will receive TECNIS Odyssey IOLs (toric or non-toric) in both eyes. Surgeries are scheduled 1 to 30 days apart with standardized implantation of the Odyssey lenses. The study will measure refractive and visual outcomes at distance, intermediate, and near, along with patient-reported satisfaction. The protocol is designed to address the unique optical challenges of post-LASIK corneas, such as altered curvature and higher-order aberrations, at a single clinical site.

Who should consider this trial

Good fit: Adults aged 50 or older with bilateral cataracts and a history of myopic LASIK who are candidates for bilateral TECNIS Odyssey IOL implantation and can complete follow-up visits.

Not a fit: Patients with glaucoma (except suspects), uveitis, clinically significant macular or other retinal disease, or other ocular findings limiting visual potential are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the Odyssey IOL could provide improved multi-distance vision and reduce spectacle dependence for patients who previously had myopic LASIK and develop cataracts.

How similar studies have performed: Previous reports of TECNIS and other presbyopia-correcting IOLs in post-LASIK eyes have shown promising but variable outcomes, mainly because IOL power calculations after LASIK are more challenging.

Eligibility criteria

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.

Where this trial is running

Venice, Florida

• Center For Sight — Venice, Florida, United States (Recruiting)

Study contacts

• Principal investigator: Joaquin K De Rojas, MD — Center For Sight
• Study coordinator: Helga P Sandoval

Conditions Cataract