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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01615861

Enrollment

103

Registered

2012-06-11

Start date

2012-11-08

Completion date

2015-06-16

Last updated

2019-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Brief 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

Interventions

PROCEDUREIOL implantation

Micro-incision phacoemulsification cataract surgery (C-MICS) and IOL implantation with 1.8mm cartridge tip insertion technique.

DEVICEIOL Implantation

Micro-incision phacoemulsification cataract surgery (B-MICS) and IOL implantation with 1.4mm wound-assist insertion technique.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Visual Acuity	6 months	Corrected distance visual acuity (CDVA)

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026