Trials Sponsors Conditions Drugs Pricing

Conditions

Refractive Lens Exchange

Outcome Measures

Primary Outcomes (4)

Binocular Photopic Visual Acuity
Measured at distance (6m), intermediate at 66cm, and near visual acuity at 40cm and 33cm.
2 months posoperatively
Monocular Photopic Visual Acuity
Measured at distance (6m), intermediate at 66cm, and near visual acuity at 40cm and 33cm.
2 months posoperatively
Monocular Defocus Curve (right eye only)
2 months posoperatively
Binocular Defocus Curve
2 months posoperatively

Secondary Outcomes (1)

Assessment of IntraOcular Lens Implant Symptoms (AIOLIS) Questionnaire
2 months posoperatively

Other Outcomes (3)

Percentage of patients within ± 0.5 D MRSE
2 months posoperatively
Percentage of eyes requiring additional corneal refractive procedures
2 months postoperative
Correlation between pupil size and defocus curve
2 months postoperative

Study Arms (1)

Odyssey IOL

Bilateral Implantation with the Odyssey IOL

Device: Odyssey IOL

Interventions

Odyssey IOLDevice

Bilateral implantation with the Odyssey IOL

Odyssey IOL

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age40 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Eligible test subjects will be aged 40 years and older who underwent bilateral implantation with the Odyssey IOL.

You may qualify if:

Participants will include 40 patients aged 40 years and older who have a measurable Potential Acuity Meter (PAM) of 20/20 electing to undergo bilateral refractive lensectomy surgery with IOL implantation.

Sponsors & Collaborators

Mann Eye Institute
Otherlead
Sengi
Industrycollaborator

Study Sites (1)

Mann Eye Institute

Houston, Texas, 76134-2099, United States

Study Officials

Phillip Brunson, OD
Mann Eye Institute
PRINCIPAL INVESTIGATOR

Enrollment

40 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 13, 2025

First Posted

May 20, 2025

Study Start

July 21, 2025

Actual (reported)

RLE Outcomes With Bilateral Implantation of Odyssey IOLs

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (1)

Other Outcomes (3)

Study Arms (1)

Odyssey IOL

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (1)

Other Outcomes (3)

Study Arms (1)

Odyssey IOL

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations