Evaluating the Need for the 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.

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Key information

Conditions

Cataract Astigmatism Cortical Cataract Eye Diseases Lens Diseases Nuclear Sclerosis Posterior Subcapsular Cataract Refractive Errors

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alterman Modi and Wolter Ophthalmic Physicians and Surgeons

Poughkeepsie, New York, 12603, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pseudophakic Measurement

Diagnostic Test

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 outcomes

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)

Sponsors and collaborators

Lead sponsor

Alterman, Modi, & Wolter Ophthalmic Physicians & Surgeons

Other

Registry information

Official study title

Evaluating the Need for Pseudophakic Intraoperative Abberrometry in Toric IOL Implantation

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Jan 29, 2019
Registry last updated: Jan 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed