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

Clalit Health Services

Status: Unknown

Conditions: Cataract

Treatments: Procedure: Conventional Phaco; Procedure: Phacoemulsification using an ACM as the sole fluid source

Study type: Interventional

Funder types: Other

Identifiers

NCT01553760

0163-11-MMC

Details and patient eligibility

About

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).

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

20 participants in 2 patient groups

Tri-MICS

Experimental group

Treatment:

Procedure: Phacoemulsification using an ACM as the sole fluid source

Conventional Phaco

Active Comparator group

Treatment:

Procedure: Conventional Phaco