We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Outcomes Following Phacoemulsification With 1.8 & 2.2mm Incision: Randomized Clinical Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01385878
Recruitment Status : Unknown
Verified June 2011 by Iladevi Cataract and IOL Research Center.
Recruitment status was:  Recruiting
First Posted : June 30, 2011
Last Update Posted : June 30, 2011
Sponsor:
Information provided by:

June 29, 2011
June 30, 2011
June 30, 2011
January 2011
December 2011   (Final data collection date for primary outcome measure)
Ingress of Trypan blue from the Ocular Surface into the Anterior Chamber [ Time Frame: Immediately at the end of surgery ]
At end of surgery, stromal hydration of all incisions will be performed.0.0125% trypan blue will be instilled on the conjunctival surface.After 2 minutes, the surface will be irrigated with balanced salt solution. 0.1ml aqeous aspirate will be obtained from the anterior chamber.Concentration of trypan blue in the aspirate will be ascertained by UV visible spectrophotometry. Log dilutions of concentration of trypan blue will be used for statistical analysis
Same as current
No Changes Posted
  • Surgically Induced Astigmatism [ Time Frame: At baseline and 3 months postoperatively ]
  • Corneal Endothelial Cell Loss [ Time Frame: Baseline and 3 months postoperatively ]
  • Change in Central Corneal Thickness [ Time Frame: Baseline and 1 week ]
  • Anterior Chamber Inflammation [ Time Frame: Baseline and 1 week ]
  • Anterior Chamber Inflammation [ Time Frame: Baseline and 1 month ]
Same as current
Not Provided
Not Provided
 
Outcomes Following Phacoemulsification With 1.8 & 2.2mm Incision: Randomized Clinical Trial
Intraoperative Performance & Postoperative Outcomes Following Phacoemulsification With 1.8 & 2.2mm Incision: Randomized Clinical Trial

Cataract surgical techniques have significantly changed in recent years with the widespread adoption of smaller and smaller clear corneal incisions for phacoemulsification. Microincision surgery has many advantages, including reduced surgically induced astigmatism, faster visual recovery, and reduced intra and postoperative inflammation. Curently, microcoaxial phacoemulsification is being performed through 1.8 as well as 2.2 mm incisions. However, there is still a debate as to which is the best absolute incision size for microcoaxial cataract surgery.

The aim of this study is to evaluate incision stability following microcoaxial phacoemulsification performed through 1.8 and 2.2 mm systems, as well as compare intraoperative performance and postoperative outcomes following microcoaxial phacoemulsification performed through these two incision sizes.

Cataract surgical techniques have significantly changed in recent years with the widespread adoption of smaller and smaller clear corneal incisions for phacoemulsification. Microincision surgery has many advantages, including reduced surgically induced astigmatism, faster visual recovery, and reduced intra and postoperative inflammation. In the recent times, microcoaxial phacoemulsification has gained popularity. The main advantage of this newer technique is that it uses the same methods as the conventional method but with smaller incisions. Curently, microcoaxial phacoemulsification is being performed through 1.8 as well as 2.2 mm incisions. However, there is still a debate as to which is the best absolute incision size for microcoaxial cataract surgery.

The aim of this study is to evaluate incision stability following microcoaxial phacoemulsification performed through 1.8 and 2.2 mm systems, as well as compare intraoperative performance and postoperative outcomes following microcoaxial phacoemulsification performed through these two incision sizes.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Cataract
  • Procedure: Microcoaxial Phacoemulsification
    Phacoemulsification through small clear corneal incision
  • Procedure: Microcoaxial Phacoemulsification
    Phacoemulsification through clear corneal incision
  • Procedure: Microcoaxial Phacoemulsification
    Microcoaxial Phacoemulsification through 1.8mm incision
  • Procedure: Microcoaxial Phacoemulsification
    Microcoaxial phacoemulsification through 2.2mm incision
  • Active Comparator: Phacoemulsification with 1.8mm incision
    Microcoaxial phacoemulsification was performed using a 1.8mm clear corneal incision
    Interventions:
    • Procedure: Microcoaxial Phacoemulsification
    • Procedure: Microcoaxial Phacoemulsification
    • Procedure: Microcoaxial Phacoemulsification
  • Active Comparator: Phacoemulsification with 2.2mm incisi
    Microcoaxial phacoemulsificaiton will be performed through 2.2mm incision
    Interventions:
    • Procedure: Microcoaxial Phacoemulsification
    • Procedure: Microcoaxial Phacoemulsification
    • Procedure: Microcoaxial Phacoemulsification
    • Procedure: Microcoaxial Phacoemulsification
Lee KM, Kwon HG, Joo CK. Microcoaxial cataract surgery outcomes: comparison of 1.8 mm system and 2.2 mm system. J Cataract Refract Surg. 2009 May;35(5):874-80. doi: 10.1016/j.jcrs.2008.12.031.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
110
December 2011
December 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria: Uncomplicated age related cataracts, NO grade II III, IV (LOCS III classification)

Exclusion Criteria:

  • Ocular comorbidity, glaucoma, uveitis, shallow anterior chamber, maximal pupillary dilatation <6mm, high myopia (axial length > 25mm), previous ocular trauma or surgery, pseudoexfoliation, traumatic cataract, subluxated cataract
Sexes Eligible for Study: All
50 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
India
 
 
NCT01385878
ICIRC-1.8 VS 2.2
Yes
Not Provided
Not Provided
Dr. Abhay R. Vasavada, Director, Iladevi Cataract & IOL Research Centre, Iladevi Cataract & IOL Research Centre
Iladevi Cataract and IOL Research Center
Not Provided
Principal Investigator: Abhay R Vasavada, MS, FRCS Iladevi Cataract and IOL Research Center
Iladevi Cataract and IOL Research Center
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP