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

Study Overview
=================
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.

Official Title
-----------------
Evaluating the Need for Pseudophakic Intraoperative Abberrometry in Toric IOL Implantation

Conditions
-----------------
Cataract, Nuclear Sclerosis, Cortical Cataract, Posterior Subcapsular Cataract, Astigmatism

Intervention / Treatment
-----------------
* Diagnostic Test: Pseudophakic Measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Aphakic Measure only<br>Eye measured in aphakic state only | |
| Active Comparator: Pseudophakic measure<br>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<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cataract surgery, cataract, toric IOL