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

NCT ID: NCT01553760

Last Updated: 2012-03-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2013-03-31

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.

Conditions

Cataract

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

Tri-MICS

Group Type: EXPERIMENTAL

Phacoemulsification using an ACM as the sole fluid source

Intervention Type: PROCEDURE

A Tri-MICS system will be used with a sleeveless Kelman 20G tip through a 1.1mm CCI. A specialized 19G anterior chamber maintainer, with thin walls and a large internal diameter of 0.9mm will be inserted through a 1.1mm CCI.

Conventional Phaco

Group Type: ACTIVE_COMPARATOR

Conventional Phaco

Intervention Type: PROCEDURE

a conventional Phaco with sleeved Kelman 20G tip, through a 2.4mm CCI

Interventions

Phacoemulsification using an ACM as the sole fluid source

A Tri-MICS system will be used with a sleeveless Kelman 20G tip through a 1.1mm CCI. A specialized 19G anterior chamber maintainer, with thin walls and a large internal diameter of 0.9mm will be inserted through a 1.1mm CCI.

Intervention Type: PROCEDURE

Conventional Phaco

a conventional Phaco with sleeved Kelman 20G tip, through a 2.4mm CCI

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Meir Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Abulafia Adi

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Meir Medical Center

Kfar Saba, , Israel

Countries

Israel

Facility Contacts

Adi Abulafia, MD

Role: primary

adi.abulafia@gmail.com

+972-9-7472154

Yafit Steren, SC

Role: backup

yafit.steren@clalit.org.il

+972-9-7471707

Other Identifiers

0163-11-MMC

Identifier Type: -

Identifier Source: org_study_id