Astigmatism, Cataract, Cortical Cataract, Nuclear Sclerosis, Posterior Subcapsular Cataract
Conditions
Keywords
cataract surgery, cataract, toric IOL
Brief summary
To determine clinically significant difference in results obtained from cataract surgery using IA. One eye will receive aphakic measurements only and the fellow eye will receive aphakic and then pseudophakic measurements when implanting a toric IOL.
Detailed description
To determine if there is a clinically significant difference in the results obtained for the toric IOL implantation when using IA to measure the aphakic eye only and when using IA to measure the aphakic eye and then the pseudophakic eye, with toric IOL implantation.
Interventions
DIAGNOSTIC_TESTPseudophakic Measurement
standard aphakic measurements will be taken and then pseudophakic measurements will be taken after toric iol implantation. The data produced will aid the surgeon in proper placement of toric iol orientation
Sponsors
Alterman, Modi, & Wolter Ophthalmic Physicians & Surgeons
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* willing and able to understand and sign an informed consent * willing and able to attend all study visits * presenting for uncomplicated bilateral cataract surgery and have an interest in a toric iol * have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error) * have visually significant cataracts * have regular corneal astigmatism of 1.0D to 5.0D in both eyes with a difference between eyes of 1.0D or less * have potential post operative acuity of 20/25 or better
Exclusion criteria
* corneal pathology * amblyopia * prior corneal refractive surgery or other refractive surgery * previous anterior or posterior chamber surgery that the investigator feels may compromise visual outcomes * Diabetic retinopathy if the investigator feels this will compromise visual outcomes * macular degeneration * history of retinal detachment * irregular astigmatism or keratoconus * strabismus * if in the surgeon's opinion the subject is not an appropriate candidate for iol implantation * subjects who have an acute or chronic disease or illness that would confound the results of this investigation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinically significant difference in results obtained for tori iol implantation when using IA | 30 days | Difference in magnitude of residual refractive astigmatism between groups Percentage of eyes with 0.50D or less of postoperative residual refractive astigmatism at 1 month post-op in each sub-group * Percentage of eyes within 0.50D of intended spherical equivalent * Sub-group analysis: * Vector analysis of the effects of any toric IOL realignment suggested by pseudophakic IA (i.e. was it likely to improve or worsen residual refractive astigmatism and/or UCVA) |
Countries
United States
Outcome results
None listed