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

NCT03819842 | Completed DMC FDA Device

• 1 other identifier: SSM--2017-12
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract; Nuclear Sclerosis; Cortical Cataract; Posterior Subcapsular Cataract; Astigmatism

Keywords

cataract surgery; cataract; toric IOL

Outcome Measures

Primary Outcomes (1)

• 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)

  30 days

Study Arms (2)

Aphakic Measure only

NO INTERVENTION

Eye measured in aphakic state only

Pseudophakic measure

ACTIVE COMPARATOR

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

Interventions

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

Pseudophakic measure

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alterman, Modi, & Wolter Ophthalmic Physicians & Surgeons: lead

Study Sites (1)

Alterman Modi and Wolter Ophthalmic Physicians and Surgeons

Poughkeepsie, New York, 12603, United States

Location

MeSH Terms

Conditions

Cataract; Astigmatism

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: January 29, 2019
• Study Start: March 19, 2018
• Primary Completion: January 14, 2019
• Study Completion: January 14, 2019
• Last Updated: January 20, 2022

Record last verified: 2022-01

Locations

US (1)