Evaluating visual outcomes after bilateral implantation of Odyssey IOLs
Ambispective Analysis of Patient Reported Outcomes and Visual Acuity in Patients Undergoing a Refractive Lens Exchange With Bilateral Implantation Odyssey Intraocular Lenses
This study is testing how well the Odyssey intraocular lens improves vision for people aged 40 and older who have had surgery to replace both of their eye lenses.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Mann Eye Institute Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06979557 on ClinicalTrials.gov |
What this trial studies
This observational study assesses the visual outcomes of patients who undergo bilateral refractive lens exchange with the Odyssey intraocular lens (IOL). Conducted at a single center, participants aged 40 and older will be evaluated at least two months post-surgery. Clinical assessments will include the AIOLIS questionnaire and measurements of visual acuity at various distances, along with refractive outcomes. The study aims to provide insights into the effectiveness of the Odyssey IOL in improving vision.
Who should consider this trial
Good fit: Ideal candidates are patients aged 40 years and older with a measurable Potential Acuity Meter of 20/20 who are electing to undergo bilateral refractive lensectomy surgery.
Not a fit: Patients with significant ocular comorbidities or those who have had prior intraocular surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of visual outcomes and improve patient satisfaction following refractive lens exchange.
How similar studies have performed: While this study focuses on a specific IOL, similar studies assessing visual outcomes with different IOLs have shown promising results, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Houston, Texas
- Mann Eye Institute — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Phillip Brunson, OD — Mann Eye Institute
- Study coordinator: Melissa Hamann Wright
- Email: melissa.wright@manneye.com
- Phone: 832-368-0117
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.