Astigmatism, Cataract
Conditions
Brief summary
The purpose of this study is to evaluate visual distortions reported by pseudophakic patients.
Interventions
Sponsors
Abbott Medical Optics
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Corneal astigmatism of at least 0.75 diopters * Bilaterally-implanted with monofocal toric intraocular lenses in both eyes or with monofocal non-toric intraocular lenses in both eyes * At least one month postoperative from second-eye surgery * Ability to understand, read and write English to give consent and complete study questionnaire * Availability, willingness, and sufficient cognitive awareness to comply with examination procedures and study visits * Sign informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization * Other protocol-defined inclusion criteria may apply
Exclusion criteria
* Any ocular pathology of clinical significance, as determined by the investigator, other than regular corneal astigmatism, that may affect visual outcomes or influence subjective ocular visual symptoms * Patient is pregnant or is lactating * Participation in any other clinical trial during the last 30 days prior to study enrollment or concurrent participation in any other ongoing clinical trial * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Distortion Symptoms | Baseline | Subjective rating of visual distortion symptoms under overall conditions at baseline. Rating scale consisted of the following categories: did not experience (rating = 0), mild (rating = 1), moderate (rating = 2), or severe (rating = 3), therefore, the lower values represent the best outcome. The minimum score was 0 and the maximum score was 3. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pseudophakic Implanted With Toric IOL Subjects implanted with bilateral toric IOL
Administration of patient self-assessment | 45 |
| Pseudophakic Implanted With Non-toric IOL Subjects implanted with bilateral non-toric IOL
Administration of patient self-assessment | 34 |
| Total | 79 |
Baseline characteristics
| Characteristic | Pseudophakic Implanted With Non-toric IOL | Pseudophakic Implanted With Toric IOL | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 participants | 0 participants | 0 participants |
| Age, Categorical >=65 years | 25 participants | 36 participants | 61 participants |
| Age, Categorical Between 18 and 65 years | 9 participants | 8 participants | 17 participants |
| Age, Continuous | 69.68 years STANDARD_DEVIATION 11.08 | 71.39 years STANDARD_DEVIATION 8.34 | 70.64 years STANDARD_DEVIATION 9.59 |
| Region of Enrollment United States | 34 participants | 45 participants | 79 participants |
| Sex: Female, Male Female | 18 Participants | 23 Participants | 41 Participants |
| Sex: Female, Male Male | 16 Participants | 22 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 45 | 2 / 34 |
| serious Total, serious adverse events | 0 / 45 | 0 / 34 |
Outcome results
Primary
Visual Distortion Symptoms
Subjective rating of visual distortion symptoms under overall conditions at baseline. Rating scale consisted of the following categories: did not experience (rating = 0), mild (rating = 1), moderate (rating = 2), or severe (rating = 3), therefore, the lower values represent the best outcome. The minimum score was 0 and the maximum score was 3.
Time frame: Baseline
Population: Of the 45 subjects in the Pseudophakic implanted with toric IOL group, one (#102) was excluded due to a protocol deviation (improper method used to simulate visual distortion).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pseudophakic Implanted With Toric IOL | Visual Distortion Symptoms | Flat surfaces appear curved | 0.64 rating of visual distortion symptoms | Standard Deviation 0.97 |
| Pseudophakic Implanted With Toric IOL | Visual Distortion Symptoms | Objects have different size/shape | 0.75 rating of visual distortion symptoms | Standard Deviation 0.99 |
| Pseudophakic Implanted With Toric IOL | Visual Distortion Symptoms | objects appear further away/closer than they are | 0.66 rating of visual distortion symptoms | Standard Deviation 0.78 |
| Pseudophakic Implanted With Toric IOL | Visual Distortion Symptoms | physical discomfort related to vision | 0.73 rating of visual distortion symptoms | Standard Deviation 0.9 |
| Pseudophakic Implanted With Toric IOL | Visual Distortion Symptoms | Lines that tilt/slant | 0.89 rating of visual distortion symptoms | Standard Deviation 1.13 |
| Pseudophakic Implanted With Non-toric IOL | Visual Distortion Symptoms | physical discomfort related to vision | 0.56 rating of visual distortion symptoms | Standard Deviation 0.75 |
| Pseudophakic Implanted With Non-toric IOL | Visual Distortion Symptoms | Lines that tilt/slant | 0.38 rating of visual distortion symptoms | Standard Deviation 0.65 |
| Pseudophakic Implanted With Non-toric IOL | Visual Distortion Symptoms | Flat surfaces appear curved | 0.38 rating of visual distortion symptoms | Standard Deviation 0.55 |
| Pseudophakic Implanted With Non-toric IOL | Visual Distortion Symptoms | objects appear further away/closer than they are | 0.56 rating of visual distortion symptoms | Standard Deviation 0.7 |
| Pseudophakic Implanted With Non-toric IOL | Visual Distortion Symptoms | Objects have different size/shape | 0.62 rating of visual distortion symptoms | Standard Deviation 0.92 |
Primary
Visual Distortion Symptoms
Subjective rating of visual distortion symptoms under overall conditions at baseline. Rating scale consisted of the following categories: did not experience (rating = 0), mild (rating = 1), moderate (rating = 2), or severe (rating = 3), therefore, the lower values represent the best outcome. The minimum score was 0 and the maximum score was 3.
Time frame: 1 week
Population: Of the 45 subjects in the Pseudophakic implanted with toric IOL group, one (#307) was excluded due to a protocol deviation (subject visit was completed outside of the protocol-defined visit interval).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pseudophakic Implanted With Toric IOL | Visual Distortion Symptoms | Flat surfaces appear curved | 0.64 rating of visual distortion symptoms | Standard Deviation 0.87 |
| Pseudophakic Implanted With Toric IOL | Visual Distortion Symptoms | Objects have different size/shape | 0.61 rating of visual distortion symptoms | Standard Deviation 0.84 |
| Pseudophakic Implanted With Toric IOL | Visual Distortion Symptoms | physical discomfort related to vision | 0.59 rating of visual distortion symptoms | Standard Deviation 0.92 |
| Pseudophakic Implanted With Toric IOL | Visual Distortion Symptoms | objects appear further away/closer than they are | 0.64 rating of visual distortion symptoms | Standard Deviation 0.78 |
| Pseudophakic Implanted With Toric IOL | Visual Distortion Symptoms | Lines that tilt/slant | 0.82 rating of visual distortion symptoms | Standard Deviation 0.95 |
| Pseudophakic Implanted With Non-toric IOL | Visual Distortion Symptoms | Objects have different size/shape | 0.47 rating of visual distortion symptoms | Standard Deviation 0.79 |
| Pseudophakic Implanted With Non-toric IOL | Visual Distortion Symptoms | Lines that tilt/slant | 0.65 rating of visual distortion symptoms | Standard Deviation 0.85 |
| Pseudophakic Implanted With Non-toric IOL | Visual Distortion Symptoms | Flat surfaces appear curved | 0.38 rating of visual distortion symptoms | Standard Deviation 0.6 |
| Pseudophakic Implanted With Non-toric IOL | Visual Distortion Symptoms | objects appear further away/closer than they are | 0.47 rating of visual distortion symptoms | Standard Deviation 0.61 |
| Pseudophakic Implanted With Non-toric IOL | Visual Distortion Symptoms | physical discomfort related to vision | 0.47 rating of visual distortion symptoms | Standard Deviation 0.79 |