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

• Sponsor: Bausch & Lomb Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01615861
• Collaborator: (none)
• Enrollment: 103
• Location: 1
• Arm: 1
• Actual Duration (Months): 31.2
• Patients Per Site Per Month: 3.3

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Cataract	Procedure: IOL implantation; Device: IOL Implantation	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 103 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Evaluation of Clinical Outcomes Following Implantation of a Sub-2mm Hydrophilic MICS Intraocular Lens
• Actual Study Start Date: Nov 8, 2012
• Actual Primary Completion Date: Jun 16, 2015
• Actual Study Completion Date: Jun 16, 2015

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Visual Acuity [6 months]

   Corrected distance visual acuity (CDVA)

Secondary Outcome Measures

1. Incision size [6 Months]

   Incision size before and after implantation

2. Refraction [6 Months]

   Manifest refraction spherical equivalent. Accuracy to target refraction

3. Visual Acuity [6 Months]

   Uncorrected distance visual acuity (UDVA)

4. EPCO [24 Months]

   3 mm evaluation of posterior capsule opacification (EPCO) score

5. Lens decentration [6 Months]

6. Laser capsulotomy [24 Months]

   Removal of post-surgical, posterior capsular opacification (PCO)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Bausch & Lomb	Labege		France	31670

Sponsors and Collaborators

• Bausch & Lomb Incorporated

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bausch & Lomb Incorporated
• ClinicalTrials.gov Identifier: NCT01615861
• Other Study ID Numbers: 714
• First Posted: Jun 11, 2012
• Last Update Posted: Nov 14, 2019
• Last Verified: Nov 1, 2019

• Additional relevant MeSH terms: Cataract

Study Results

No Results Posted as of Nov 14, 2019