Evaluation of Clinical Outcomes Following Implantation of a Sub-2mm Hydrophilic MICS Intraocular Lens

Study Overview
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Brief Summary
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The objective of this study is to evaluate clinical outcomes following sub-2 mm micro-incision cataract surgery (MICS) and intraocular lens (IOL) implantation. This study is evaluated in two Phases V4 (6M) endpoint: primary analysis V5 (12M) and V6 (34M): EPCO score and Nd Yag incidence analysis

Official Title
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Evaluation of Clinical Outcomes Following Implantation of a Sub-2mm Hydrophilic MICS Intraocular Lens

Conditions
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Cataract

Intervention / Treatment
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* Procedure: IOL implantation
* Device: IOL Implantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must have clear intraocular media other than cataract in the study eye. Subjects must have a clinically documented diagnosis of age-related cataract that is considered amenable to treatment with micro-incision phacoemulsification cataract extraction in the study eye. Exclusion Criteria: Subjects with ocular malformation in the study eye. Subjects who have had previous surgery in the study eye. Subjects with uncontrolled glaucoma in either eye. Subjects with any anterior segment pathology for which micro-incision phacoemulsification cataract surgery would be contraindicated Subjects using medications known to potentially complicate cataract surgery.

Ages Eligible for Study
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Minimum Age: 40 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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IOL implantation<br>Hydrophilic acrylic lens implantation through a micro-incision phacoemulsification and cataract surgery (MICS) | Procedure: IOL implantation<br>* Micro-incision phacoemulsification cataract surgery (C-MICS) and IOL implantation with 1.8mm cartridge tip insertion technique.<br>Device: IOL Implantation<br>* Micro-incision phacoemulsification cataract surgery (B-MICS) and IOL implantation with 1.4mm wound-assist insertion technique.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity | Corrected distance visual acuity (CDVA) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incision size | Incision size before and after implantation | 6 Months | 
| Refraction | Manifest refraction spherical equivalent. Accuracy to target refraction | 6 Months | 
| Visual Acuity | Uncorrected distance visual acuity (UDVA) | 6 Months | 
| EPCO | 3 mm evaluation of posterior capsule opacification (EPCO) score | 24 Months | 
| Lens decentration |  | 6 Months | 
| Laser capsulotomy | Removal of post-surgical, posterior capsular opacification (PCO) | 24 Months |