Cataract
Conditions
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.
Interventions
DEVICETECNIS Odyssey IOL
Implantation with the TECNIS Odyssey IOL
Sponsors
Mann Eye Institute
Sengi
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. Perceptions about general vision are asked on a 5 item scale (Poor, Fair, Good, Very good, Excellent). Poor is considered a worse outcome. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORPhillip Brunson, OD
Mann Eye Institute
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 63.6 years STANDARD_DEVIATION 6.9 |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 40 |
| other Total, other adverse events | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
None listed