Health TrialsbyHealthPanel

Odyssey Evaluation in Post LASIK Patients

ConditionCataract
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age50+
SponsorCenter For Sight

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: 50 years and older.

Gender: Males and Females.

Bilateral cataracts

Bilateral implantation of Odyssey IOLs (toric and non-toric)

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Odyssey intraocular lens

    Device

    The Odyssey intraocular lens is intended to be implanted at the time of cataract surgery to replace the natural lens.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Odyssey IOLOther 1 intervention

Trial outcomes

Primary outcomes

1

Binocular defocus curve

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.

Time frame
3 months postoperatively

Secondary outcomes

1

Patient satisfaction

Percentage of patients who reported being completely, mostly, moderately, a little or not at all satisfied with overall vision

Time frame
3 months postoperatively
2

Spectacle independence at near.

Percentage of patients who reported wearing glasses none of the time or a little of the time for near activities (16 inches/40 cm).

Time frame
3 months postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Center For Sight

Lead sponsor

Sengi Clinical

Collaborator

Source ClinicalTrials.gov
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