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Evaluation of Clinical Outcomes Following Implantation of a Sub-2mm Hydrophilic MICS Intraocular Lens
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2014 by Bausch & Lomb Incorporated.
Recruitment status was: Active, not recruiting
Recruitment status was: Active, not recruiting
Sponsor:
Bausch & Lomb Incorporated
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01615861
First received: May 29, 2012
Last updated: March 27, 2014
Last verified: March 2014
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Cataract | Procedure: IOL implantation Device: IOL Implantation | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | Evaluation of Clinical Outcomes Following Implantation of a Sub-2mm Hydrophilic MICS Intraocular Lens |
Resource links provided by NLM:
Further study details as provided by Bausch & Lomb Incorporated:
Primary Outcome Measures:
- Visual Acuity [ Time Frame: 6 months ]Corrected distance visual acuity (CDVA)
Secondary Outcome Measures:
- 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)
| Enrollment: | 103 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 40 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01615861
Please refer to this study by its ClinicalTrials.gov identifier: NCT01615861
Locations
| France | |
| Bausch & Lomb | |
| Labege, France, 31670 | |
Sponsors and Collaborators
Bausch & Lomb Incorporated
More Information
| Responsible Party: | Bausch & Lomb Incorporated |
| ClinicalTrials.gov Identifier: | NCT01615861 History of Changes |
| Other Study ID Numbers: |
714 |
| Study First Received: | May 29, 2012 |
| Last Updated: | March 27, 2014 |
Additional relevant MeSH terms:
|
Cataract Lens Diseases Eye Diseases |
ClinicalTrials.gov processed this record on June 21, 2017