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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03819842
Recruitment Status : Completed
First Posted : January 29, 2019
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
Alterman, Modi, & Wolter Ophthalmic Physicians & Surgeons

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.

Condition or disease Intervention/treatment Phase
Cataract Nuclear Sclerosis Cortical Cataract Posterior Subcapsular Cataract Astigmatism Diagnostic Test: Pseudophakic Measurement Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluating the Need for Pseudophakic Intraoperative Abberrometry in Toric IOL Implantation
Actual Study Start Date : March 19, 2018
Actual Primary Completion Date : January 14, 2019
Actual Study Completion Date : January 14, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
No Intervention: Aphakic Measure only
Eye measured in aphakic state only
Active Comparator: 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.
Diagnostic Test: 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




Primary Outcome Measures :
  1. Clinically significant difference in results obtained for tori iol implantation when using IA [ Time Frame: 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03819842


Locations
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United States, New York
Alterman Modi and Wolter Ophthalmic Physicians and Surgeons
Poughkeepsie, New York, United States, 12603
Sponsors and Collaborators
Alterman, Modi, & Wolter Ophthalmic Physicians & Surgeons

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Responsible Party: Alterman, Modi, & Wolter Ophthalmic Physicians & Surgeons
ClinicalTrials.gov Identifier: NCT03819842     History of Changes
Other Study ID Numbers: SSM--2017-12
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Results of the study may be shared at international meeting s and submitted for peer review

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Alterman, Modi, & Wolter Ophthalmic Physicians & Surgeons:
cataract surgery
cataract
toric IOL

Additional relevant MeSH terms:
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Cataract
Astigmatism
Lens Diseases
Eye Diseases
Refractive Errors