Clinical Investigation of Refraction Techniques

Study Overview
=================
Brief Summary
-----------------
Prospective, multi-center, non-interventional, randomized, comparative clinical study to identify an optimal refractive technique that provides maximum plus refractive endpoint for best corrected distance visual acuity (BCDVA).

Official Title
-----------------
Clinical Investigation of Refraction Techniques

Conditions
-----------------
Refractive Error

Intervention / Treatment
-----------------
* Device: Refractive Technique (MR #1)
* Device: Refractive Technique (MR #2)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant in PCOL-102-AHSF who were bilaterally implanted with TECNIS IOL, Models C1V000, C2V000 or ICB00 and have completed and are at least 30 days postoperative from their second eye surgery; At least one implanted eye with clear ocular media; Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in Australia and New Zealand; Availability, willingness and sufficient cognitive awareness to comply with examination procedures. Exclusion Criteria: Best-corrected distance visual acuity (BCDVA) worse than 0.66 decimal (6/9 or 20/30 Snellen); Subjects with ongoing adverse events that might impact outcomes during the study visit as determined by the investigator.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MR #1/MR #2<br>Subjects who participated in PCOL-102-AHSF who were bilaterally implanted with TECNIS IOL lenses will be randomized into the (MR #1/MR #2) sequence and receive two different maximum refractive techniques one at a time consecutively. | Device: Refractive Technique (MR #1)<br>* Fogging method that employs fogging lens to ensure there is sufficient visual defocus to induce blur.<br>Device: Refractive Technique (MR #2)<br>* Duochrome method that employs the chromatic aberration of the eye, with the shorter wavelengths (green) focused in front of the longer (red) wavelengths<br>|
| MR#2/MR#1<br>Subjects who participated in PCOL-102-AHSF who were bilaterally implanted with TECNIS IOL lenses will be randomized into the (MR#2/MR#1) sequence and receive two different maximum refractive techniques one at a time consecutively. | Device: Refractive Technique (MR #1)<br>* Fogging method that employs fogging lens to ensure there is sufficient visual defocus to induce blur.<br>Device: Refractive Technique (MR #2)<br>* Duochrome method that employs the chromatic aberration of the eye, with the shorter wavelengths (green) focused in front of the longer (red) wavelengths<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between two manifest refractive techniques on outcome variable MRSE | Refractive technique 1 will use a plus lens fogging technique and refractive technique 2 will use the Duochrome technique to achieve maximum plus refraction for best-corrected visual acuity (BCDVA). | Day 0 | 
| Difference between two manifest refractive techniques on visual acuity | Refractive technique 1 will use a plus lens fogging technique and refractive technique 2 will use the Duochrome technique to achieve maximum plus refraction for best-corrected visual acuity (BCDVA). | Day 0 |