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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01615861
• Other study ID #: 714
• Status: Completed
• Phase: N/A
• Start date: November 8, 2012
• Est. completion date: June 16, 2015

Study information

• Verified date: November 2019
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: June 16, 2015
• Est. primary completion date: June 16, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract

Intervention

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.

Locations

Country	Name	City	State
France	Bausch & Lomb	Labege

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Acuity	Corrected distance visual acuity (CDVA)	6 months
Secondary	Incision size	Incision size before and after implantation	6 Months
Secondary	Refraction	Manifest refraction spherical equivalent. Accuracy to target refraction	6 Months
Secondary	Visual Acuity	Uncorrected distance visual acuity (UDVA)	6 Months
Secondary	EPCO	3 mm evaluation of posterior capsule opacification (EPCO) score	24 Months
Secondary	Lens decentration		6 Months
Secondary	Laser capsulotomy	Removal of post-surgical, posterior capsular opacification (PCO)	24 Months