Cataract
Conditions
Brief summary
This study is a single center, multi-surgeon, prospective, randomized, comparative study of binocular corrected distance visual acuity (CDVA) after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at up to 6 postoperative visits. Clinical evaluations will include administration of patient reported spectacle usage questionnaire (PRSIQ), as well as measurement of monocular and binocular visual acuities at distance, intermediate, and near, defocus curve, manifest refraction, measurement of higher order aberrations.
Interventions
DEVICEClareon Monofocal
Clareon Monofocal Intraocular Lens (toric and non-toric)
DEVICELight-Adjustable Lens
Light-Adjustable Lens (Intraocular Lens)
Sponsors
Gainesville Eye Associates
Sengi
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Subjects are eligible for the study if they meet the following criteria: Note: Ocular criteria must be met in both eyes. * Adult patients undergoing age-related cataract surgery with expected best- corrected visual outcomes of 20/25 or better * Regular corneal astigmatism of 0.75D-2.50D * Dilated pupil diameter of 7mm or greater
Exclusion criteria
If any of the following
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Binocular Corrected Distance Visual Acuity (CDVA) | 3 months postop |
Secondary
| Measure | Time frame |
|---|---|
| Binocular Uncorrected Distance Visual Acuity (UDVA) | 3 months postop |
| Binocular Distance Corrected Intermediate Visual Acuity (DCIVA) | 3 months postop |
| Binocular Uncorrected Intermediate Visual Acuity (UIVA) | 3 months postop |
| Monocular Corrected Distance Visual Acuity (CDVA) | 3 months postop |
| Monocular Uncorrected Distance Visual Acuity (UDVA) | 3 months postop |
| Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) | 3 months postop |
| Monocular Uncorrected Intermediate Visual Acuity (UIVA) | 3 months postop |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORClayton G Blehm, MD
Gainesville Eye Associates
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 70.8 Years STANDARD_DEVIATION 7.6 |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 83 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 70 | 0 / 68 |
| other Total, other adverse events | 6 / 70 | 14 / 68 |
| serious Total, serious adverse events | 0 / 70 | 0 / 68 |
Outcome results
None listed