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

Not Applicable

Completed

• Conditions: Cataract; Nuclear Sclerosis; Astigmatism; Cortical Cataract; Posterior Subcapsular Cataract
• Interventions: Diagnostic Test: Pseudophakic Measurement

• Registration Number: NCT03819842
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2018-03-19
• Primary Completion: 2019-01-14
• Study Completion: 2019-01-14
• Study First Submitted: 2019-01-22
• Study First Submitted QC: 2019-01-24
• Study First Posted: 2019-01-29
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-05
• Last Update Posted: 2022-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pseudophakic measure	Pseudophakic Measurement	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.

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Alterman Modi and Wolter Ophthalmic Physicians and Surgeons; 🇺🇸 Poughkeepsie, New York, United States