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

January 5, 2022 updated by: Alterman, Modi, & Wolter Ophthalmic Physicians & Surgeons

Evaluating the Need for Pseudophakic Intraoperative Abberrometry in Toric IOL Implantation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Poughkeepsie, New York, United States, 12603
        • Alterman Modi and Wolter Ophthalmic Physicians and Surgeons

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alterman, Modi, & Wolter Ophthalmic Physicians & Surgeons

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 19, 2018

Primary Completion (Actual)

January 14, 2019

Study Completion (Actual)

January 14, 2019

Study Registration Dates

First Submitted

January 22, 2019

First Submitted That Met QC Criteria

January 24, 2019

First Posted (Actual)

January 29, 2019

Study Record Updates

Last Update Posted (Actual)

January 20, 2022

Last Update Submitted That Met QC Criteria

January 5, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SSM--2017-12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Results of the study may be shared at international meetings and submitted for peer review

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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