Evaluation of Clinical Outcomes Following Implantation of a Sub-2mm Hydrophilic MICS Intraocular Lens
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ClinicalTrials.gov Identifier: NCT01615861 |
Recruitment Status
: Unknown
Verified March 2014 by Bausch & Lomb Incorporated.
Recruitment status was: Active, not recruiting
First Posted
: June 11, 2012
Last Update Posted
: March 28, 2014
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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
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cataract | Procedure: IOL implantation Device: IOL Implantation | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 103 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Official Title: | Evaluation of Clinical Outcomes Following Implantation of a Sub-2mm Hydrophilic MICS Intraocular Lens |
Study Start Date : | November 2012 |
Estimated Primary Completion Date : | October 2014 |
Estimated Study Completion Date : | December 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: IOL implantation
Hydrophilic acrylic lens implantation through a micro-incision phacoemulsification and cataract surgery (MICS)
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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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- Visual Acuity [ Time Frame: 6 months ]Corrected distance visual acuity (CDVA)
- Incision size [ Time Frame: 6 Months ]Incision size before and after implantation
- Refraction [ Time Frame: 6 Months ]Manifest refraction spherical equivalent. Accuracy to target refraction
- Visual Acuity [ Time Frame: 6 Months ]Uncorrected distance visual acuity (UDVA)
- EPCO [ Time Frame: 24 Months ]3 mm evaluation of posterior capsule opacification (EPCO) score
- Lens decentration [ Time Frame: 6 Months ]
- Laser capsulotomy [ Time Frame: 24 Months ]Removal of post-surgical, posterior capsular opacification (PCO)

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Ages Eligible for Study: | 40 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01615861
France | |
Bausch & Lomb | |
Labege, France, 31670 |
Responsible Party: | Bausch & Lomb Incorporated |
ClinicalTrials.gov Identifier: | NCT01615861 History of Changes |
Other Study ID Numbers: |
714 |
First Posted: | June 11, 2012 Key Record Dates |
Last Update Posted: | March 28, 2014 |
Last Verified: | March 2014 |
Additional relevant MeSH terms:
Cataract Lens Diseases Eye Diseases |