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

Study Overview
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Brief Summary
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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
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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: 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. 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. This procedure allows a free use of the surgeon's second hand. A fixed intraocular infusion keeps the intraocular pressure (IOP) and anterior chamber volume constant and stable.

Conditions
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Cataract

Intervention / Treatment
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* Procedure: Phacoemulsification using an ACM as the sole fluid source
* Procedure: Conventional Phaco


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tri-MICS<br> | Procedure: Phacoemulsification using an ACM as the sole fluid source<br>* 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.<br>|
| Active Comparator: Conventional Phaco<br> | Procedure: Conventional Phaco<br>* a conventional Phaco with sleeved Kelman 20G tip, through a 2.4mm CCI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal temperature | Continuous corneal temperature will be measured during cataract surgery using an infra red thermal imaging system | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cataract, TRI-MICS, ACM, MICS, phacoemulsification