Clinical Outcomes With Bilateral Implantation of Odyssey IOLs

Completed

• Conditions: Cataract
• Interventions: Device: TECNIS Odyssey IOL

• Registration Number: NCT06550375
• Lead Sponsor: Mann Eye Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-09
• Study First Submitted QC: 2024-08-09
• Study First Posted: 2024-08-13
• Study Start: 2024-09-05
• Primary Completion: 2025-03-26
• Study Completion: 2025-03-26
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-08
• Last Update Posted: 2025-05-11

Recruitment & Eligibility

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

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TECNIS Odyssey IOL	TECNIS Odyssey IOL	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Assessment of IntraOcular Lens Implant Symptoms (AIOLIS) Questionniare	3 months postoperative	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