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

Not Applicable

Completed

• Conditions: Cataract
• Interventions: Device: IOL Implantation

• Registration Number: NCT01615861
• Lead Sponsor: Bausch & Lomb Incorporated

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

* V4 (6M) endpoint: primary analysis

* V5 (12M) and V6 (34M): EPCO score and Nd Yag incidence analysis

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-05-29
• Study First Submitted QC: 2012-06-07
• Study First Posted: 2012-06-11
• Study Start: 2012-11-08
• Primary Completion: 2015-06-16
• Study Completion: 2015-06-16
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-12
• Last Update Posted: 2019-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IOL implantation	IOL Implantation	Hydrophilic acrylic lens implantation through a micro-incision phacoemulsification and cataract surgery (MICS)

Primary Outcome Measures

Name	Time	Method
Visual Acuity	6 months	Corrected distance visual acuity (CDVA)

Secondary Outcome Measures

Name	Time	Method
Lens decentration	6 Months
Laser capsulotomy	24 Months	Removal of post-surgical, posterior capsular opacification (PCO)
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

Trial Locations

Locations (1)

Bausch & Lomb; 🇫🇷 Labege, France