Trials / Completed
CompletedNCT01615861
Evaluation of Clinical Outcomes Following Implantation of a Sub-2mm Hydrophilic MICS Intraocular Lens
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 103 (actual)
- Sponsor
- Bausch & Lomb Incorporated · Industry
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2012-11-08
- Primary completion
- 2015-06-16
- Completion
- 2015-06-16
- First posted
- 2012-06-11
- Last updated
- 2019-11-14
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT01615861. Inclusion in this directory is not an endorsement.