Clinical Outcomes With Bilateral Implantation of Odyssey IOLs

March 19, 2026 updated by: Mann Eye Institute

Ambispective Analysis of Patient Reported Outcomes and Visual Acuity in Patients With Bilateral Implantation of Odyssey Intraocular Lenses

This study is a single center, ambispective study of visual outcomes after successful bilateral cataract surgery. Subjects will be assessed at least 3 months postoperatively at a single visit. Clinical evaluations will include administration of the AIOLIS and OSDI questionnaires, as well as measurement of visual acuities at distance, intermediate, and near.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

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

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 76134-2099
        • Mann Eye Institute

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Eligible test subjects will be aged 50 years and older who underwent bilateral cataract surgery with Odyssey IOL implantation.

Description

Inclusion Criteria:

• Patients aged 50 years and older who underwent bilateral cataract surgery with Odyssey IOL implantation.

Exclusion Criteria:

  • Significant ocular comorbidities (e.g., macular degeneration, glaucoma).
  • < 2 weeks post YAG capsulotomy.
  • Best corrected distance visual acuity worse than 20/25.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
TECNIS Odyssey IOL
Device: TECNIS Odyssey IOL
Implantation with the TECNIS Odyssey IOL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Acuity at Distance (6m) logMAR
Time Frame: 3 months postoperative
Photopic and mesopic, binocular and monocular, and uncorrected and distance corrected
3 months postoperative
Visual Acuity at Intermediate (66cm) logMAR
Time Frame: 3 months postoperative
Photopic and mesopic, binocular and monocular, and uncorrected and distance corrected
3 months postoperative
Visual Acuity at Near (40cm) logMAR
Time Frame: 3 months postoperative
Photopic and mesopic, binocular and monocular, and uncorrected and distance corrected
3 months postoperative
Visual Acuity at Near (33cm) logMAR
Time Frame: 3 months postoperative
Photopic and mesopic, binocular and monocular, and uncorrected and distance corrected
3 months postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of IntraOcular Lens Implant Symptoms (AIOLIS) Questionniare
Time Frame: 3 months postoperative
The AIOLIS has 37 questions about symptoms, perceptions of general vision, and frequency of wearing glasses or contact lenses. Perceptions about general vision are asked on a 5 item scale (Poor, Fair, Good, Very good, Excellent). Poor is considered a worse outcome.
3 months postoperative

Collaborators and Investigators

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

Sponsor

Mann Eye Institute

Collaborators

Sengi

Investigators

  • Principal Investigator: Phillip Brunson, OD, Mann Eye Institute

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)

September 5, 2024

Primary Completion (Actual)

March 26, 2025

Study Completion (Actual)

March 26, 2025

Study Registration Dates

First Submitted

August 9, 2024

First Submitted That Met QC Criteria

August 9, 2024

First Posted (Actual)

August 13, 2024

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PB-24-01

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.

Yes

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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