Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-02-28 @ 10:38 PM
Study NCT ID:
NCT01553760
Status:
UNKNOWN
Last Update Posted:
2012-03-14
First Post:
2012-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of an Anterior Chamber Maintainer as a Sole Fluid Source in Micro Incision Cataract Surgery as Compared to a Standard Phacoemulsification Procedure
Sponsor:
Meir Medical Center
Organization:
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2012-03
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: