Status:

COMPLETED

Evaluating the Need for the Pseudophakic Intraoperative Abberrometry in Toric IOL Implantation

Lead Sponsor:

Alterman, Modi, & Wolter Ophthalmic Physicians & Surgeons

Conditions:

Cataract

Nuclear Sclerosis

Eligibility:

All Genders

30+ years

Phase:

NA

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 pseud...

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 aphak...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

March 19 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 14 2019

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT03819842

Start Date

March 19 2018

End Date

January 14 2019

Last Update

January 20 2022

Active Locations (1)

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Alterman Modi and Wolter Ophthalmic Physicians and Surgeons

Poughkeepsie, New York, United States, 12603