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

Cataract Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01553760
• Other study ID #: 0163-11-MMC
• Status: Not yet recruiting
• Phase: N/A
• First received: February 19, 2012
• Last updated: March 13, 2012
• Start date: March 2012
• Est. completion date: March 2013

Study information

• Verified date: March 2012
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cataract

Intervention

Procedure:
• 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.
• Conventional Phaco
a conventional Phaco with sleeved Kelman 20G tip, through a 2.4mm CCI

Locations

Country	Name	City	State
Israel	Meir Medical Center	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneal temperature	Continuous corneal temperature will be measured during cataract surgery using an infra red thermal imaging system	up to 12 months	Yes
Secondary	Anterior chamber stability	Anterior chamber stability will be accessed during cataract surgery by the surgeon and post op by two different observers using surgery video record.	up to 12 months	Yes