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

Cataract Clinical Trial

Official title:

Evaluating the Need for Pseudophakic Intraoperative Abberrometry in Toric IOL Implantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03819842
• Other study ID #: SSM--2017-12
• Status: Completed
• Phase: N/A
• Start date: March 19, 2018
• Est. completion date: January 14, 2019

Study information

• Verified date: January 2022
• Source: Alterman, Modi, & Wolter Ophthalmic Physicians & Surgeons
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 14, 2019
• Est. primary completion date: January 14, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Astigmatism
• Cataract
• Cortical Cataract
• Nuclear Sclerosis
• Posterior Subcapsular Cataract

Intervention

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

Locations

Country	Name	City	State
United States	Alterman Modi and Wolter Ophthalmic Physicians and Surgeons	Poughkeepsie	New York

Sponsors (1)

Lead Sponsor	Collaborator
Alterman, Modi, & Wolter Ophthalmic Physicians & Surgeons

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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