Cataract
Conditions
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.
Interventions
DEVICEOdyssey intraocular lens
The Odyssey intraocular lens is intended to be implanted at the time of cataract surgery to replace the natural lens.
Sponsors
Sengi Clinical
Center For Sight
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Binocular defocus curve | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction | 3 months postoperatively | Percentage of patients who reported being completely, mostly, moderately, a little or not at all satisfied with overall vision |
| Spectacle independence at near. | 3 months postoperatively | Percentage of patients who reported wearing glasses none of the time or a little of the time for near activities (16 inches/40 cm). |
Countries
United States
Contacts
Primary ContactHelga P Sandoval
Outcome results
None listed