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

NCT ID: NCT01385878

Last Updated: 2011-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-12-31

Brief Summary

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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

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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.

Conditions

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Cataract

Keywords

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Microcoaxial phacoemulsification, 1.8mm, 2.2mm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Phacoemulsification with 1.8mm incision

Microcoaxial phacoemulsification was performed using a 1.8mm clear corneal incision

Group Type ACTIVE_COMPARATOR

Microcoaxial Phacoemulsification

Intervention Type PROCEDURE

Phacoemulsification through small clear corneal incision

Microcoaxial Phacoemulsification

Intervention Type PROCEDURE

Phacoemulsification through clear corneal incision

Microcoaxial Phacoemulsification

Intervention Type PROCEDURE

Microcoaxial Phacoemulsification through 1.8mm incision

Phacoemulsification with 2.2mm incisi

Microcoaxial phacoemulsificaiton will be performed through 2.2mm incision

Group Type ACTIVE_COMPARATOR

Microcoaxial Phacoemulsification

Intervention Type PROCEDURE

Phacoemulsification through small clear corneal incision

Microcoaxial Phacoemulsification

Intervention Type PROCEDURE

Phacoemulsification through clear corneal incision

Microcoaxial Phacoemulsification

Intervention Type PROCEDURE

Microcoaxial Phacoemulsification through 1.8mm incision

Microcoaxial Phacoemulsification

Intervention Type PROCEDURE

Microcoaxial phacoemulsification through 2.2mm incision

Interventions

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Microcoaxial Phacoemulsification

Phacoemulsification through small clear corneal incision

Intervention Type PROCEDURE

Microcoaxial Phacoemulsification

Phacoemulsification through clear corneal incision

Intervention Type PROCEDURE

Microcoaxial Phacoemulsification

Microcoaxial Phacoemulsification through 1.8mm incision

Intervention Type PROCEDURE

Microcoaxial Phacoemulsification

Microcoaxial phacoemulsification through 2.2mm incision

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

\-

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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Iladevi Cataract and IOL Research Center

OTHER

Sponsor Role lead

Responsible Party

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Iladevi Cataract & IOL Research Centre

Principal Investigators

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Abhay R Vasavada, MS, FRCS

Role: PRINCIPAL_INVESTIGATOR

Iladevi Cataract and IOL Research Center

Locations

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Iladevi Cataract & IOL Research Centre

Ahmedabad, Gujarat, India

Site Status RECRUITING

Countries

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India

Central Contacts

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Abhay R Vasavada, MS,FRCS

Role: CONTACT

Phone: 91-79-27490909

Email: [email protected]

Vaishali A Vasavada, MS

Role: CONTACT

Phone: 91-79-27492303

Email: [email protected]

Facility Contacts

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Abhay r Vasavada, MS,FRCS

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 19393887 (View on PubMed)

Other Identifiers

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ICIRC-1.8 VS 2.2

Identifier Type: -

Identifier Source: org_study_id