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Recruiting NCT07260695

Odyssey Evaluation in Post LASIK Patients

Phase IV Interventional Cataract

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Odyssey intraocular lens.
Who it may be relevant to
Registry conditions: Cataract. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Device 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 measures

  • Binocular defocus curve [Time frame: 3 months postoperatively]
Secondary outcome measures (2)
  • Patient satisfaction [Time frame: 3 months postoperatively]
  • Spectacle independence at near. [Time frame: 3 months postoperatively]

Eligibility criteria

Inclusion criteria

Subjects MUST fulfill the following conditions to qualify for enrollment into the trial

  • Age: 50 years and older.
  • Gender: Males and Females.
  • Bilateral cataracts
  • Bilateral implantation of Odyssey IOLs (toric and non-toric)
  • Scheduled to undergo standard cataract surgery in both eyes, within 1 to 30 days between surgeries.
  • Willing and able to provide written informed consent for participation in the study.
  • Willing and able to comply with scheduled visits and study examination procedures.
  • 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.

  • 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.
  • Uncontrolled diabetes.
  • Use of any systemic or topical drug known to interfere with visual performance.
  • Any concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis.
  • Clinically significant corneal dystrophy.
  • Contact lens use during the active treatment portion of the trial.
  • Irregular astigmatism.
  • Corneal irregularities potentially affecting visual acuity (i.e., keratoconus, corneal opacities
  • History of chronic intraocular inflammation.
  • History of retinal detachment.
  • Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules.
  • Previous intraocular surgery.
  • Previous keratoplasty
  • Previous refractive surgery other than myopic LASIK or PRK (i.e., radial keratotomy, hyperopic LASIK, etc)
  • Severe dry eye.
  • Pupil abnormalities.
  • 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).
  • Any clinically significant, serious, or severe medical or psychiatric condition that may interfere with the interpretation of study results.
  • 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.
  • Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.)
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Center For Sight — Venice

Identifiers

NCT: NCT07260695 · CFS 25-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗