Actively Recruiting
Odyssey Evaluation in Post LASIK Patients
Led by Center For Sight · Updated on 2025-12-03
30
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
C
Center For Sight
Lead Sponsor
S
Sengi Clinical
Collaborating Sponsor
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Odyssey Evaluation in Post LASIK Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 50 years or older
- Male or female gender
- Presence of cataracts in both eyes
- Planned bilateral implantation of Odyssey intraocular lenses (toric or non-toric)
- Scheduled cataract surgeries on both eyes within 1 to 30 days apart
- Willing and able to give written informed consent
- Willing and able to attend scheduled visits and undergo study examinations
- Postoperative best corrected visual acuity of 0.2 logMAR (20/32 Snellen) or better in each eye
You will not qualify if you...
- Presence of ocular diseases such as glaucoma (except suspects), uveitis, or retinal disease affecting the macula with vision worse than 20/25
- Uncontrolled diabetes
- Use of systemic or topical drugs that affect visual performance
- Any active conjunctivitis, keratitis, or uveitis
- Significant corneal dystrophy
- Use of contact lenses during the treatment phase
- Irregular astigmatism or corneal irregularities affecting vision
- History of chronic eye inflammation
- History of retinal detachment
- Pseudoexfoliation syndrome or conditions weakening eye zonules
- Previous intraocular surgery
- Previous keratoplasty
- Previous refractive surgery other than myopic LASIK or PRK
- Severe dry eye
- Pupil abnormalities
- Likely need for additional eye surgery during the study (except YAG capsulotomy or LASIK)
- Serious medical or psychiatric conditions affecting study results
- Participation in other eye device or drug trials within 30 days prior
- Inability to maintain steady fixation or focus for long periods
- Abnormal iris
- Investigator discretion of patient unsuitability for the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Center For Sight
Venice, Florida, United States, 34285
Actively Recruiting
Research Team
H
Helga P Sandoval
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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