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Clinical Trials/NCT06550375
NCT06550375
Completed
Not Applicable

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

Mann Eye Institute1 site in 1 country40 target enrollmentSeptember 5, 2024
ConditionsCataract

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cataract
Sponsor
Mann Eye Institute
Enrollment
40
Locations
1
Primary Endpoint
Visual Acuity at Near (40cm) logMAR
Status
Completed
Last Updated
11 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 5, 2024
End Date
March 26, 2025
Last Updated
11 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Visual Acuity at Near (40cm) logMAR

Time Frame: 3 months postoperative

Photopic and mesopic, binocular and monocular, and uncorrected and distance corrected

Visual Acuity at Near (33cm) logMAR

Time Frame: 3 months postoperative

Photopic and mesopic, binocular and monocular, and uncorrected and distance corrected

Visual Acuity at Distance (6m) logMAR

Time Frame: 3 months postoperative

Photopic and mesopic, binocular and monocular, and uncorrected and distance corrected

Visual Acuity at Intermediate (66cm) logMAR

Time Frame: 3 months postoperative

Photopic and mesopic, binocular and monocular, and uncorrected and distance corrected

Secondary Outcomes

  • Assessment of IntraOcular Lens Implant Symptoms (AIOLIS) Questionniare(3 months postoperative)

Study Sites (1)

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