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

Primary Purpose

Cataract, Nuclear Sclerosis, Cortical Cataract

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Pseudophakic Measurement

About this trial

This is an interventional treatment trial for Cataract focused on measuring cataract surgery, cataract, toric IOL

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Alterman Modi and Wolter Ophthalmic Physicians and Surgeons

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Aphakic Measure only

Pseudophakic measure

Arm Description

Eye measured in aphakic state only

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.

Outcomes

Primary Outcome Measures

Clinically significant difference in results obtained for tori iol implantation when using IA

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)

Secondary Outcome Measures

Full Information

NCT ID

NCT03819842

First Posted

January 22, 2019

Last Updated

January 5, 2022

Sponsor

Alterman, Modi, & Wolter Ophthalmic Physicians & Surgeons

1. Study Identification

Unique Protocol Identification Number

NCT03819842

Brief Title

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

Official Title

Evaluating the Need for Pseudophakic Intraoperative Abberrometry in Toric IOL Implantation

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Completed

Study Start Date

March 19, 2018 (Actual)

Primary Completion Date

January 14, 2019 (Actual)

Study Completion Date

January 14, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alterman, Modi, & Wolter Ophthalmic Physicians & Surgeons

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cataract, Nuclear Sclerosis, Cortical Cataract, Posterior Subcapsular Cataract, Astigmatism

Keywords

cataract surgery, cataract, toric IOL

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Aphakic Measure only

Arm Type

No Intervention

Arm Description

Eye measured in aphakic state only

Arm Title

Pseudophakic measure

Arm Type

Active Comparator

Arm Description

Intervention Type

Diagnostic Test

Intervention Name(s)

Pseudophakic Measurement

Intervention Description

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 Measure Information:

Title

Clinically significant difference in results obtained for tori iol implantation when using IA

Description

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Alterman Modi and Wolter Ophthalmic Physicians and Surgeons

City

Poughkeepsie

State/Province

New York

ZIP/Postal Code

12603

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

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

Learn more about this trial

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

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