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

Sponsor

Alterman, Modi, & Wolter Ophthalmic Physicians & Surgeons (Other)

Overall Status

Completed

CT.gov ID

NCT03819842

Collaborator

(none)

Enrollment

Location

Arms

9.9

Actual Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract Nuclear Sclerosis Cortical Cataract Posterior Subcapsular Cataract Astigmatism	Diagnostic Test: Pseudophakic Measurement	N/A

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 Design

Study Type:

Interventional

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 :

Mar 19, 2018

Actual Primary Completion Date :

Jan 14, 2019

Actual Study Completion Date :

Jan 14, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alterman Modi and Wolter Ophthalmic Physicians and Surgeons	Poughkeepsie	New York	United States	12603

Sponsors and Collaborators

Alterman, Modi, & Wolter Ophthalmic Physicians & Surgeons

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alterman, Modi, & Wolter Ophthalmic Physicians & Surgeons

ClinicalTrials.gov Identifier:

NCT03819842

Other Study ID Numbers:

SSM--2017-12

First Posted:

Jan 29, 2019

Last Update Posted:

Jan 20, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

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.:

Keywords provided by Alterman, Modi, & Wolter Ophthalmic Physicians & Surgeons

cataract surgery

cataract

toric IOL

Additional relevant MeSH terms:

Cataract

Astigmatism

Study Results

No Results Posted as of Jan 20, 2022