The Use of an Anterior Chamber Maintainer as a Sole Fluid Source in Micro Incision Cataract Surgery as Compared to a Standard Phacoemulsification Procedure

Not Applicable

• Conditions: Cataract
• Interventions: Procedure: Conventional Phaco; Procedure: Phacoemulsification using an ACM as the sole fluid source

• Registration Number: NCT01553760
• Lead Sponsor: Meir Medical Center

Brief Summary

The purpose of this study is to compare the use of an Anterior Chamber Maintainer (ACM) as the sole fluid source in phacoemulsification micro incision cataract surgery (using 1.1mm corneal incision) as opposed to conventional coaxial phacoemulsification (using 2.4mm corneal incision).

Detailed Description

Three-port Micro Incision Cataract Surgery (Tri-MICS) is a technique suggested by Professor Assia. The idea (principle) behind the Tri-MICS technique is the use of a sleeveless phaco needle which is introduced via a tiny incision (1.1mm). An additional corneal incision is made for the introduction of a second surgical instrument, and a third for an ACM as an exclusive source for the infusion - this saves the need for an additional instrument. The ACM that will be used in this study (AVI New York) is a small metal tube with an external diameter of 1.1 mm, and an internal diameter of 0.9 mm and was developed specifically for this use. This type of ACM has been used in hundreds of surgeries and has been found to be both effective and safe.

This procedure has 4 clear advantages:

1. The implementation of three corneal incisions, 1.1 mm wide with an angle of approximately 120 degrees between them - neutrality regarding astigmatism versus the Biaxial-MICS.

2. This procedure does not require any special medical instruments, for example; new phaco instruments which are specifically adapted for the MICS approach at the cost of tens of thousands of dollars.

3. This procedure allows a free use of the surgeon's second hand.

4. A fixed intraocular infusion keeps the intraocular pressure (IOP) and anterior chamber volume constant and stable.

Study Timeline

• Study First Submitted: 2012-02-19
• Status Verified: 2012-03
• Study Start: 2012-03
• Study First Submitted QC: 2012-03-13
• Last Update Submitted: 2012-03-13
• Study First Posted: 2012-03-14
• Last Update Posted: 2012-03-14
• Primary Completion: 2013-03
• Study Completion: 2013-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Bilateral Cataract
• Ability to understand and sign on an inform consent form.
• whiling to undergo bilateral cataract surgery.

Exclusion Criteria

• Mature Cataract
• PXF
• Uveitis
• Corneal Pathology
• Endothelial cell density<1500 cells/mm
• Glaucoma
• Extreme Hyperopia / shallow anterior chamber
• Extreme Myopia
• s/p Ophthalmic Trauma / Surgery
• Allergy to Penicillin / IOD

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Phaco	Conventional Phaco	-
Tri-MICS	Phacoemulsification using an ACM as the sole fluid source	-

Primary Outcome Measures

Name	Time	Method
Corneal temperature	up to 12 months	Continuous corneal temperature will be measured during cataract surgery using an infra red thermal imaging system

Secondary Outcome Measures

Name	Time	Method
Anterior chamber stability	up to 12 months	Anterior chamber stability will be accessed during cataract surgery by the surgeon and post op by two different observers using surgery video record.

Trial Locations

Locations (1)

Meir Medical Center; 🇮🇱 Kfar Saba, Israel