Evaluation of Clinical Outcomes Following Implantation of a Sub-2mm Hydrophilic MICS Intraocular Lens
Study Details
Study Description
Brief Summary
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
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V4 (6M) endpoint: primary analysis
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V5 (12M) and V6 (34M): EPCO score and Nd Yag incidence analysis
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: IOL implantation Hydrophilic acrylic lens implantation through a micro-incision phacoemulsification and cataract surgery (MICS) |
Procedure: IOL implantation
Micro-incision phacoemulsification cataract surgery (C-MICS) and IOL implantation with 1.8mm cartridge tip insertion technique.
Device: IOL Implantation
Micro-incision phacoemulsification cataract surgery (B-MICS) and IOL implantation with 1.4mm wound-assist insertion technique.
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Outcome Measures
Primary Outcome Measures
- Visual Acuity [6 months]
Corrected distance visual acuity (CDVA)
Secondary Outcome Measures
- Incision size [6 Months]
Incision size before and after implantation
- Refraction [6 Months]
Manifest refraction spherical equivalent. Accuracy to target refraction
- Visual Acuity [6 Months]
Uncorrected distance visual acuity (UDVA)
- EPCO [24 Months]
3 mm evaluation of posterior capsule opacification (EPCO) score
- Lens decentration [6 Months]
- Laser capsulotomy [24 Months]
Removal of post-surgical, posterior capsular opacification (PCO)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subjects must have clear intraocular media other than cataract in the study eye.
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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:
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Subjects with ocular malformation in the study eye.
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Subjects who have had previous surgery in the study eye.
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Subjects with uncontrolled glaucoma in either eye.
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Subjects with any anterior segment pathology for which micro-incision phacoemulsification cataract surgery would be contraindicated
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Subjects using medications known to potentially complicate cataract surgery.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Bausch & Lomb | Labege | France | 31670 |
Sponsors and Collaborators
- Bausch & Lomb Incorporated
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 714