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

March 13, 2012 updated by: Abulafia Adi, Meir Medical Center
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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Kfar Saba, Israel
        • Meir Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tri-MICS
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.
Active Comparator: Conventional Phaco
Procedure: Conventional Phaco
a conventional Phaco with sleeved Kelman 20G tip, through a 2.4mm CCI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Corneal temperature
Time Frame: up to 12 months
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
Time Frame: 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.
up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meir Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Anticipated)

March 1, 2013

Study Completion (Anticipated)

March 1, 2013

Study Registration Dates

First Submitted

February 19, 2012

First Submitted That Met QC Criteria

March 13, 2012

First Posted (Estimate)

March 14, 2012

Study Record Updates

Last Update Posted (Estimate)

March 14, 2012

Last Update Submitted That Met QC Criteria

March 13, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0163-11-MMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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