NCT01553760

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2012

Completed
11 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 14, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

March 14, 2012

Status Verified

March 1, 2012

Enrollment Period

1 year

First QC Date

February 19, 2012

Last Update Submit

March 13, 2012

Conditions

Cataract

Keywords

CataractTRI-MICSACMMICSphacoemulsification

Outcome Measures

Primary Outcomes (1)

  • Corneal temperature

    Continuous corneal temperature will be measured during cataract surgery using an infra red thermal imaging system

    up to 12 months

Secondary Outcomes (1)

  • Anterior chamber stability

    up to 12 months

Study Arms (2)

Tri-MICS

EXPERIMENTAL
Procedure: Phacoemulsification using an ACM as the sole fluid source

Conventional Phaco

ACTIVE COMPARATOR
Procedure: Conventional Phaco

Interventions

Phacoemulsification using an ACM as the sole fluid sourcePROCEDURE

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.

Tri-MICS
Conventional PhacoPROCEDURE

a conventional Phaco with sleeved Kelman 20G tip, through a 2.4mm CCI

Conventional Phaco

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Bilateral Cataract
  • Ability to understand and sign on an inform consent form.
  • whiling to undergo bilateral cataract surgery.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 19, 2012

First Posted

March 14, 2012

Study Start

March 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

March 14, 2012

Record last verified: 2012-03

Locations

IL(1)