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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Iladevi Cataract and IOL Research Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Iladevi Cataract and IOL Research Center
ClinicalTrials.gov Identifier:
NCT01385878
First received: June 29, 2011
Last updated: NA
Last verified: June 2011
History: No changes posted

June 29, 2011
June 29, 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • Corneal Endothelial Cell Loss [ Time Frame: Baseline and 3 months postoperatively ] [ Designated as safety issue: No ]
  • Change in Central Corneal Thickness [ Time Frame: Baseline and 1 week ] [ Designated as safety issue: No ]
  • Anterior Chamber Inflammation [ Time Frame: Baseline and 1 week ] [ Designated as safety issue: No ]
  • Anterior Chamber Inflammation [ Time Frame: Baseline and 1 month ] [ Designated as safety issue: No ]
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 Blind (Subject, 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
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
Both
50 Years to 80 Years
No
Contact: Abhay R Vasavada, MS,FRCS 91-79-27490909 icirc@abhayvasavada.com
Contact: Vaishali A Vasavada, MS 91-79-27492303 icirc@abhayvasavada.com
India
 
NCT01385878
ICIRC-1.8 VS 2.2
Yes
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