Cataract
Conditions
Brief summary
To evaluate spectacle independence and patient satisfaction and visual outcomes after bilateral PanOptix implantation in patients with previous multifocal contact lens experience.
Detailed description
This study is a single-arm unmasked clinical evaluation study of patient satisfaction after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at 1 day, 1 week and 3 months post-operatively. Clinical evaluations will include administration of a visual disturbance questionnaire (QUVID), and a satisfaction questionnaire (IOLSAT), as well as measurement of bilateral visual acuity and manifest refraction.
Interventions
Bilateral implantation with the Clareon PanOptix Trifocal (toric and non-toric models)
Sponsors
Sengi
Vivid Laser Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Inclusion criteria
Subjects are eligible for the study if they meet the following criteria: Note: Ocular criteria must be met in both eyes. * Adult cataract patients undergoing uncomplicated cataract surgery with Clareon PanOptix IOL implantation (non-toric/toric). * Visually significant cataracts bilaterally. * History of successful soft multifocal contact lens use in the past (within ≤ last 5 years). * Healthy ocular exam. * Gender: Males and Females. * Willing and able to provide written informed consent for participation in the study. * Willing and able to comply with scheduled visits and other study procedures.
Exclusion criteria
If any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction questionnaire | 3 months postoperative | The Intraocular Lens Satisfaction questionnaire (IOLSAT). Lower scores indicate higher spectacle independence and satisfaction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Binocular uncorrected distance visual acuity (6m) | 3 months postoperative | — |
| Binocular uncorrected intermediate visual acuity (60 cm) | 3 months postoperative | — |
| Binocular uncorrected near visual acuity (40 cm) | 3 months postoperative | — |
| Binocular corrected distance visual acuity (6m) | 3 months postoperative | — |
| Manifest refraction | 3 months postoperative | — |
| Spectacle independence | 3 months postoperative | The Intraocular Lens Satisfaction questionnaire (IOLSAT). Lower scores indicate higher spectacle independence and satisfaction. |
| Binocular distance corrected intermediate visual acuity (60 cm) | 3 months postoperative | — |
| Binocular distance corrected intermediate visual acuity (40 cm) | 3 months postoperative | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Binocular distance corrected intermediate visual acuity (33 cm) | 3 months postoperative | — |
| Visual disturbances questionnaire | 3 months postoperative | Questionnaire for Visual Disturbances (QUVID). Lower scores indicate less frequent, severe, or bothersome visual disturbances. |
Countries
Canada
Outcome results
None listed