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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
  Purpose

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.


Condition Intervention
Cataract
Procedure: Microcoaxial Phacoemulsification

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intraoperative Performance & Postoperative Outcomes Following Phacoemulsification With 1.8 & 2.2mm Incision: Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Iladevi Cataract and IOL Research Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 110
Study Start Date: January 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Phacoemulsification with 1.8mm incision
Microcoaxial phacoemulsification was performed using a 1.8mm clear corneal incision
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
Active Comparator: Phacoemulsification with 2.2mm incisi
Microcoaxial phacoemulsificaiton will be performed through 2.2mm incision
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01385878

Contacts
Contact: Abhay R Vasavada, MS,FRCS 91-79-27490909 icirc@abhayvasavada.com
Contact: Vaishali A Vasavada, MS 91-79-27492303 icirc@abhayvasavada.com

Locations
India
Iladevi Cataract & IOL Research Centre Recruiting
Ahmedabad, Gujarat, India, 380009
Contact: Abhay r Vasavada, MS,FRCS       icirc@abhayvasavada.com   
Principal Investigator: Abhay R Vasavada, MS, FRCS         
Sponsors and Collaborators
Iladevi Cataract and IOL Research Center
Investigators
Principal Investigator: Abhay R Vasavada, MS, FRCS Iladevi Cataract and IOL Research Center
  More Information

Publications:
Responsible Party: Dr. Abhay R. Vasavada, Director, Iladevi Cataract & IOL Research Centre, Iladevi Cataract & IOL Research Centre
ClinicalTrials.gov Identifier: NCT01385878     History of Changes
Other Study ID Numbers: ICIRC-1.8 VS 2.2
Study First Received: June 29, 2011
Last Updated: June 29, 2011
Health Authority: India: Institutional Review Board

Keywords provided by Iladevi Cataract and IOL Research Center:
Microcoaxial phacoemulsification, 1.8mm, 2.2mm

ClinicalTrials.gov processed this record on November 20, 2014