Co-Axial Micro-Incision Versus Co-Axial Small Incision Cataract Surgery Using the Stellaris Enhancement System

Study Overview
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Brief Summary
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The objective of this study is to test the hypothesis that the time to reach a stable refraction is significantly shorter in eyes operated with the 1.8 mm coaxial microincision compared to eyes operated with the 2.75 mm standard incision using the Stellaris Vision Enhancement System.

Official Title
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Co-Axial Micro-incision Cataract Surgery(C-MICS) Versus Standard Co-Axial Small Incision Cataract Surgery Using the Stellaris Enhancement System

Conditions
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Cataract, Aphakia

Intervention / Treatment
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* Procedure: Coaxial Micro-Incision Cataract Surgery
* Procedure: Coaxial Small Incision Cataract Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must be undergoing bilateral primary in-the-bag intraocular lens (IOL) implantation for the correction of aphakia. Subject's ocular media must be clear except for the presence of the cataract in both eyes. Exclusion Criteria: Subject with any disease, which, in the Investigator's opinion, might interfere with the conduct of the study.

Ages Eligible for Study
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Minimum Age: 50 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: Coaxial Micro-Incision Cataract Surgery<br>1.8 mm coaxial microincision | Procedure: Coaxial Micro-Incision Cataract Surgery<br>* 1.8 mm coaxial micro incision<br>* Other names: Stellaris Vision Enhancement System;|
| Active Comparator: Coaxial Small Incision Cataract Surgery<br>2.75 mm standard incision | Procedure: Coaxial Small Incision Cataract Surgery<br>* 2.75 mm coaxial incision<br>* Other names: Stellaris Vision Enhancement System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Refractive Stability | Cumulative portion of eyes achieving refractive stability within 0.5 D of the final value for the remainder of the trial by surgical procedure and visit. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Corrected Visual Acuity | Best corrected distance visual acuity(BCVA) was assessed using logMAR charts. Change from preoperative visit summarized by visit. A minus change represents an improvement of the visual acuity | Visit 1, visit 2, visit 3, visit 4 | 
| Best Corrected Visual Acuity | Best corrected distance visual acuity(BCVA) was assessed using logMAR charts. Change from baseline summarized by visit. A minus change represents an improvement of the visual acuity. | visit 5, visit 6, visit 7, visit 8 | 
| Uncorrected Visual Acuity | Uncorrected visual acuity(UCVA) was assessed using logMAR charts. Change from baseline summarized by visit. | Visit 1, visit 2, visit 3, visit 4 | 
| Uncorrected Visual Acuity | Uncorrected visual acuity(UCVA) was assessed using logMAR charts. Change from baseline summarized by visit. | visit 5, visit 6, visit 7, visit 8 | 
| Surgically Induced Astigmatism (SIA) | Surgically induced astigmatism was presented in dioptres at each visit. | Visits 1-3 | 
| Surgically Induced Astigmatism (SIA) | Surgically induced astigmatism presented in dioptres at each visit. | Visits 4-8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ocular Surgery, Intraocular Lens