Evaluating the Need for the Pseudophakic Intraoperative Abberrometry in Toric IOL Implantation
NCT ID: NCT03819842
Last Updated: 2022-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2018-03-19
2019-01-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Aphakic Measure only
Eye measured in aphakic state only
No interventions assigned to this group
Pseudophakic measure
Eye measured in aphakic state then again in pseudophakic state with toric IOL using the ORA System. Pseudophakic measurement obtained will provide data about placement of toric iol and the surgeon will use that data to rotate the iol if necessary.
Pseudophakic 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
Interventions
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Pseudophakic 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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
30 Years
ALL
Yes
Sponsors
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Alterman, Modi, & Wolter Ophthalmic Physicians & Surgeons
OTHER
Responsible Party
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Locations
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Alterman Modi and Wolter Ophthalmic Physicians and Surgeons
Poughkeepsie, New York, United States
Countries
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Other Identifiers
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SSM--2017-12
Identifier Type: -
Identifier Source: org_study_id
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