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

Bausch + Lomb

Status: Completed

Conditions: Cataract

Treatments: Procedure: IOL implantation; Device: IOL Implantation

Study type: Interventional

Funder types: Industry

Identifiers

NCT01615861

714

Details and patient eligibility

About

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

Enrollment: 103 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

103 participants in 1 patient group

IOL implantation

Experimental group

Description:

Hydrophilic acrylic lens implantation through a micro-incision phacoemulsification and cataract surgery (MICS)

Treatment:

Procedure: IOL implantation

Device: IOL Implantation