NCT07260695

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
3mo left

Started Aug 2025

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress72%
Aug 2025Aug 2026

Study Start

First participant enrolled

August 18, 2025

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 22, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 3, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2026

Last Updated

December 3, 2025

Status Verified

December 1, 2025

Enrollment Period

1 year

First QC Date

August 22, 2025

Last Update Submit

December 1, 2025

Conditions

Cataract

Outcome Measures

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.

    3 months postoperatively

Secondary Outcomes (2)

  • Patient satisfaction

    3 months postoperatively

  • Spectacle independence at near.

    3 months postoperatively

Study Arms (1)

Odyssey IOL

OTHER
Device: Odyssey intraocular lens

Interventions

Odyssey intraocular lensDEVICE

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

Odyssey IOL

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center For Sight

Venice, Florida, 34285, United States

RECRUITING

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Joaquin K De Rojas, MD

    Center For Sight

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Helga P Sandoval

CONTACT

8438813937hps@cepmd.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2025

First Posted

December 3, 2025

Study Start

August 18, 2025

Primary Completion (Estimated)

August 18, 2026

Study Completion (Estimated)

August 18, 2026

Last Updated

December 3, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)