Cataract
Conditions
Brief summary
The purpose of this study is to evaluate the visual quality and function of pseudophakic patients.
Interventions
Sponsors
Abbott Medical Optics
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Minimum 22 years of age * Pseudophakic patients who have been bilaterally implanted with the same type of intraocular lenses in both eyes * Ability to understand, read and write English to give consent and complete the study questionnaires * Availability, willingness, and sufficient cognitive awareness to comply with examination procedures and study visits * Signed informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization * Other protocol-defined inclusion criteria might apply
Exclusion criteria
* Any ocular pathology of clinical significance, as determined by the investigator, that may affect visual outcomes or influence subjective ocular/visual symptoms * Patient is pregnant or is lactating * Concurrent participation or participation within 30 days prior in any other clinical trial * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Use of Corrective Visual Aids (i.e., Spectacles, Contact Lenses) Post Intraocular Lens (IOL) Surgery | Baseline and 1 week | Patients will be assessed at a baseline visit and a visit 1 week later to determine their use of corrective visual aids (i.e., spectacles, contact lenses) post Intraocular Lens (IOL) surgery. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pseudophakic .
Administration of patient self assessment | 296 |
| Total | 296 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Failed to meet inclusion criteria | 5 |
Baseline characteristics
| Characteristic | Pseudophakic |
|---|---|
| Age, Continuous | 68.79 years STANDARD_DEVIATION 8.23 |
| Sex: Female, Male Female | 194 Participants |
| Sex: Female, Male Male | 102 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 296 |
| serious Total, serious adverse events | 0 / 296 |
Outcome results
Primary
Use of Corrective Visual Aids (i.e., Spectacles, Contact Lenses) Post Intraocular Lens (IOL) Surgery
Patients will be assessed at a baseline visit and a visit 1 week later to determine their use of corrective visual aids (i.e., spectacles, contact lenses) post Intraocular Lens (IOL) surgery.
Time frame: Baseline and 1 week
Population: Of the 295 participants who provided data for this analysis (monofocal participants , n=138; accommodating participants, n=34; and multifocal participants, n=123), corrective visual aids (i.e., spectacles, contact lenses) post intraocular lens (IOL) surgery were required by 88 participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pseudophakic | Use of Corrective Visual Aids (i.e., Spectacles, Contact Lenses) Post Intraocular Lens (IOL) Surgery | Monofocal participants requiring visual aids | 71 participants |
| Pseudophakic | Use of Corrective Visual Aids (i.e., Spectacles, Contact Lenses) Post Intraocular Lens (IOL) Surgery | Accommodating participants requiring visual aids | 8 participants |
| Pseudophakic | Use of Corrective Visual Aids (i.e., Spectacles, Contact Lenses) Post Intraocular Lens (IOL) Surgery | Multifocal participants requiring visual aids | 9 participants |