CataractNCT01553760
The Use of an Anterior Chamber Maintainer as a Sole Fluid Source in Micro Incision Cataract Surgery as Compared to a Standard Phacoemulsification Procedure
A study testing Phacoemulsification using an ACM as the sole fluid source and Conventional Phaco in people with Cataract, run by Meir Medical Center at 1 site in Israel.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract
- What is being tested?
- Phacoemulsification using an ACM as the sole fluid source and Conventional Phaco
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2012to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Bilateral Cataract
- Ability to understand and sign on an inform consent form.
- whiling to undergo bilateral cataract surgery.
Who cannot join
- Mature Cataract
- PXF
- Uveitis
- Corneal Pathology
- Endothelial cell density<1500 cells/mm
- Glaucoma
Show all 10Show fewer
- Extreme Hyperopia / shallow anterior chamber
- Extreme Myopia
- s/p Ophthalmic Trauma / Surgery
- Allergy to Penicillin / IOD
Trial locations and contacts
1 site in 1 country.
Israel1 site
Meir Medical Center
Kfar Saba
Adi Abulafia, MD, +972-9-7472154, adi.abulafia@gmail.com
Yafit Steren, SC, +972-9-7471707, yafit.steren@clalit.org.il
About this study
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).
Read the 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:
- 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
- Cataract
- Being tested
- Phacoemulsification using an ACM as the sole fluid source, Conventional Phaco
- Keywords
- Cataract, TRI-MICS, ACM, MICS, phacoemulsification
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phacoemulsification using an ACM as the sole fluid sourceProcedure or surgery
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 PhacoProcedure or surgery
a conventional Phaco with sleeved Kelman 20G tip, through a 2.4mm CCI
| Study group | Role | What they receive |
|---|---|---|
| Tri-MICS | Experimental | Not described Receives: Procedure: Phacoemulsification using an ACM as the sole fluid source |
| Conventional Phaco | Active comparator | Not described Receives: Procedure: Conventional Phaco |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal temperature
Continuous corneal temperature will be measured during cataract surgery using an infra red thermal imaging system
Measured: up to 12 months
Secondary outcomes (1)
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.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionMar 2013 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abulafia Adi, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01553760
- Sponsor's protocol ID
- 0163-11-MMC
- Status last verified
- Mar 2012
- First submitted
- 19 Feb 2012
- Last updated
- 14 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01553760
- Acronym / sponsor ID
- 0163-11-MMC
- Conditions
- Cataract
- Keywords
- Cataract, TRI-MICS, ACM, MICS, phacoemulsification
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 14 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tri-MICS | Experimental | Procedure: Phacoemulsification using an ACM as the sole fluid source |
| Conventional Phaco | Active comparator | Procedure: Conventional Phaco |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Bilateral Cataract
- Ability to understand and sign on an inform consent form.
- whiling to undergo bilateral cataract surgery.
Key exclusion criteria (10 listed)
- Mature Cataract
- PXF
- Uveitis
- Corneal Pathology
- Endothelial cell density<1500 cells/mm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phacoemulsification using an ACM as the sole fluid sourceA 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. | Procedure or surgery | Tri-MICS |
| Conventional Phacoa conventional Phaco with sleeved Kelman 20G tip, through a 2.4mm CCI | Procedure or surgery | Conventional Phaco |
Primary outcome
Corneal temperature
Time frame: up to 12 months
Continuous corneal temperature will be measured during cataract surgery using an infra red thermal imaging system
1 secondary outcome
Anterior chamber stability
Time frame: up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phacoemulsification using an ACM as the sole fluid source and Conventional Phaco in people with Cataract, run by Meir Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corneal temperature (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2012.