Cataract
Conditions
Keywords
Cataract, TRI-MICS, ACM, MICS, phacoemulsification
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.
Interventions
PROCEDUREPhacoemulsification 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.
PROCEDUREConventional Phaco
a conventional Phaco with sleeved Kelman 20G tip, through a 2.4mm CCI
Sponsors
Meir Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Corneal temperature | up to 12 months | Continuous corneal temperature will be measured during cataract surgery using an infra red thermal imaging system |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Israel
Outcome results
None listed