Cataract Refractive Suite Study

Study Overview
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Brief Summary
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The purpose of this study is to compare the refractive predictability (prediction error) between the Cataract Refractive Suite (CRS) and standard manual technique at one month post-operative

Official Title
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A Prospective, Multicenter, Randomized Evaluation of Refractive Predictability in Patients With or Without Corneal Astigmatism (Maximum Allowable up to 1.25D) When Using the Cataract Refractive Suite and Standard Manual Techniques

Conditions
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Cataracts

Intervention / Treatment
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* Device: Cataract Refractive Suite (CRS)
* Procedure: Standard manual technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with bilateral cataracts; Planned cataract surgery and implantation of ReSTOR +2.5 D multifocal intraocular lens (IOL) in both eyes; Clear intraocular media, other than cataract, in study eye(s); Willing and able to complete all required postoperative visits; Able to comprehend and sign a statement of informed consent; Other protocol-specified inclusion criteria may apply. Exclusion Criteria: Significant irregular corneal astigmatism; History of or current severe dry eyes, retinal/uveal pathology or concurrent ocular disease; Previous intraocular or corneal refractive surgery, corneal transplant, or retinal detachment; Any inflammation or edema (swelling) of the cornea; Pregnant; Other protocol-specified exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CRS<br>First surgical eye randomized to Cataract Refractive Suite with second surgical eye (fellow eye) assigned to standard manual technique. Second eye surgery conducted within 7-14 days of the first eye surgery. | Device: Cataract Refractive Suite (CRS)<br>* Configuration consisting of Verion™ Image Guided System, LenSx® Laser and ORA™ System with VerifEye+™ (with or without VerifEye Lynk), combined for use in surgical pre-op planning and during cataract surgery<br>Procedure: Standard manual technique<br>* Standard biometry for intra-ocular lens (IOL) calculation and cataract removal using phacoemulsification technique<br>|
| Active Comparator: Manual<br>First surgical eye randomized to standard manual technique with second surgical eye (fellow eye) assigned to Cataract Refractive Suite. Second eye surgery conducted within 7-14 days of the first eye surgery. | Device: Cataract Refractive Suite (CRS)<br>* Configuration consisting of Verion™ Image Guided System, LenSx® Laser and ORA™ System with VerifEye+™ (with or without VerifEye Lynk), combined for use in surgical pre-op planning and during cataract surgery<br>Procedure: Standard manual technique<br>* Standard biometry for intra-ocular lens (IOL) calculation and cataract removal using phacoemulsification technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) Within 0.5 Diopter (D) of Predicted Postoperative Spherical Equivalent at Month 1 | Manifest refraction spherical equivalent (MRSE) was calculated as follows: sphere + 1/2 cylinder. The sphere and cylinder values were from the manifest refraction assessment. Manifest refraction was assessed at 4 meters under photopic lighting conditions using a phoropter. Due to early termination of the study and limited sample size, a statistical inference test was not carried out as planned. | Day 20-40 from second implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative Dissipated Energy (CDE) | Cumulative Dissipated Energy (CDE) represents the energy dissipated of the ultrasound tip and infusion sleeve at the incision point during the removal of cataractous lens. CDE was reported on the Vision System interface and measured in percent-seconds. A lower CDE indicates that less energy was expended in the eye. Due to early termination of the study and limited sample size, a statistical inference test was not carried out as planned. | Day 0 (operative day), each eye | 
| Estimated Aspiration Fluid Used During Surgery | Aspiration fluid (amount of fluid used during the removal of the cataractous lens) was measured in milliliters (ml). A lower value indicates less fluid used during the procedure. Due to early termination of the study and limited sample size, a statistical inference test was not carried out as planned. | Day 0 (operative day), each eye | 
| Phaco Aspiration Time Spent During Surgery | Phaco aspiration time (the average time the surgeon took to complete the phacoemulsification) was measured in seconds. A lower value indicates that the surgeon spent less time aspirating fluid and material from the eye during surgery. Due to early termination of the study and limited sample size, a statistical inference test was not carried out as planned. | Day 0 (operative day), each eye |