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

Primary Purpose

Cataract

Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Microcoaxial Phacoemulsification
Microcoaxial Phacoemulsification
Microcoaxial Phacoemulsification
Microcoaxial Phacoemulsification
Sponsored by
Iladevi Cataract and IOL Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring Microcoaxial phacoemulsification, 1.8mm, 2.2mm

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Iladevi Cataract & IOL Research CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Phacoemulsification with 1.8mm incision

Phacoemulsification with 2.2mm incisi

Arm Description

Microcoaxial phacoemulsification was performed using a 1.8mm clear corneal incision

Microcoaxial phacoemulsificaiton will be performed through 2.2mm incision

Outcomes

Primary Outcome Measures

Ingress of Trypan blue from the Ocular Surface into the Anterior Chamber
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
Corneal Endothelial Cell Loss
Change in Central Corneal Thickness
Anterior Chamber Inflammation
Anterior Chamber Inflammation

Full Information

First Posted
June 29, 2011
Last Updated
June 29, 2011
Sponsor
Iladevi Cataract and IOL Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT01385878
Brief Title
Outcomes Following Phacoemulsification With 1.8 & 2.2mm Incision: Randomized Clinical Trial
Official Title
Intraoperative Performance & Postoperative Outcomes Following Phacoemulsification With 1.8 & 2.2mm Incision: Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Iladevi Cataract and IOL Research Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Microcoaxial phacoemulsification, 1.8mm, 2.2mm

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phacoemulsification with 1.8mm incision
Arm Type
Active Comparator
Arm Description
Microcoaxial phacoemulsification was performed using a 1.8mm clear corneal incision
Arm Title
Phacoemulsification with 2.2mm incisi
Arm Type
Active Comparator
Arm Description
Microcoaxial phacoemulsificaiton will be performed through 2.2mm incision
Intervention Type
Procedure
Intervention Name(s)
Microcoaxial Phacoemulsification
Intervention Description
Phacoemulsification through small clear corneal incision
Intervention Type
Procedure
Intervention Name(s)
Microcoaxial Phacoemulsification
Intervention Description
Phacoemulsification through clear corneal incision
Intervention Type
Procedure
Intervention Name(s)
Microcoaxial Phacoemulsification
Intervention Description
Microcoaxial Phacoemulsification through 1.8mm incision
Intervention Type
Procedure
Intervention Name(s)
Microcoaxial Phacoemulsification
Intervention Description
Microcoaxial phacoemulsification through 2.2mm incision
Primary Outcome Measure Information:
Title
Ingress of Trypan blue from the Ocular Surface into the Anterior Chamber
Description
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
Time Frame
Immediately at the end of surgery
Secondary Outcome Measure Information:
Title
Surgically Induced Astigmatism
Time Frame
At baseline and 3 months postoperatively
Title
Corneal Endothelial Cell Loss
Time Frame
Baseline and 3 months postoperatively
Title
Change in Central Corneal Thickness
Time Frame
Baseline and 1 week
Title
Anterior Chamber Inflammation
Time Frame
Baseline and 1 week
Title
Anterior Chamber Inflammation
Time Frame
Baseline and 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abhay R Vasavada, MS,FRCS
Phone
91-79-27490909
Email
icirc@abhayvasavada.com
First Name & Middle Initial & Last Name or Official Title & Degree
Vaishali A Vasavada, MS
Phone
91-79-27492303
Email
icirc@abhayvasavada.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abhay R Vasavada, MS, FRCS
Organizational Affiliation
Iladevi Cataract and IOL Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Iladevi Cataract & IOL Research Centre
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380009
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abhay r Vasavada, MS,FRCS
Email
icirc@abhayvasavada.com
First Name & Middle Initial & Last Name & Degree
Abhay R Vasavada, MS, FRCS

12. IPD Sharing Statement

Citations:
PubMed Identifier
19393887
Citation
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.
Results Reference
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Outcomes Following Phacoemulsification With 1.8 & 2.2mm Incision: Randomized Clinical Trial

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