RLE Outcomes With Bilateral Implantation of Odyssey IOLs

Recruiting

• Conditions: Refractive Lens Exchange

• Registration Number: NCT06979557
• Lead Sponsor: Mann Eye Institute

Brief Summary

This study is a single center, ambispective study of visual outcomes after successful bilateral implantation of the Odyssey IOL. Subjects will be assessed at least 2 months postoperatively at a single visit. Clinical evaluations will include administration of the AIOLIS questionnaire, as well as measurement of visual acuities at distance, intermediate, and near, monocular (right eye) and binocular defocus curve, and refractive outcomes.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-13
• Study First Submitted QC: 2025-05-13
• Last Update Submitted: 2025-05-13
• Study First Posted: 2025-05-20
• Last Update Posted: 2025-05-20
• Study Start: 2025-05-31
• Primary Completion: 2026-06-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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.

Exclusion Criteria

• Patients with significant ocular comorbidities (e.g., macular degeneration, glaucoma) or prior intraocular surgery will be excluded.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Assessment of IntraOcular Lens Implant Symptoms (AIOLIS) Questionnaire	2 months posoperatively	The AIOLIS has 37 questions about symptoms, perceptions of general vision, and frequency of wearing glasses or contact lenses. Lower scores for the symptom questions indicate lower frequency and both of visual disturbances.

Trial Locations

Locations (1)

Mann Eye Institute; 🇺🇸 Houston, Texas, United States