Odyssey Evaluation in Post LASIK Patients

December 1, 2025 updated by: Center For Sight

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Helga P Sandoval
  • Phone Number: 8438813937
  • Email: hps@cepmd.com

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Odyssey IOL
Device: Odyssey intraocular lens
The Odyssey intraocular lens is intended to be implanted at the time of cataract surgery to replace the natural lens.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Binocular defocus curve
Time Frame: 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.
3 months postoperatively

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient satisfaction
Time Frame: 3 months postoperatively
Percentage of patients who reported being completely, mostly, moderately, a little or not at all satisfied with overall vision
3 months postoperatively
Spectacle independence at near.
Time Frame: 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).
3 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Center For Sight

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Sengi Clinical

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Joaquin K De Rojas, MD, Center for Sight

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 18, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 18, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 18, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 22, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 3, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CFS 25-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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