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

Alterman, Modi, & Wolter Ophthalmic Physicians & Surgeons

Status: Completed

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

Treatments: Diagnostic Test: Pseudophakic Measurement

Study type: Interventional

Funder types: Other

Identifiers

NCT03819842

SSM--2017-12

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 30+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

40 participants in 2 patient groups

Aphakic Measure only

No Intervention group

Description:

Eye measured in aphakic state only

Pseudophakic measure

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: Pseudophakic Measurement