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.

Study Overview

• Status: Unknown
• Conditions: Cataract
• Intervention / Treatment: Procedure: Microcoaxial Phacoemulsification; Procedure: Microcoaxial Phacoemulsification; Procedure: Microcoaxial Phacoemulsification; Procedure: Microcoaxial Phacoemulsification

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.

• Study Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Gujarat
    • Ahmedabad, Gujarat, India, 380009
      • Recruiting
      • Iladevi Cataract & IOL Research Centre
      • Contact: Abhay r Vasavada, MS,FRCS; Email: icirc@abhayvasavada.com
      • Principal Investigator: Abhay R Vasavada, MS, FRCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Procedure: Microcoaxial Phacoemulsification; Microcoaxial phacoemulsification through 2.2mm 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Immediately at the end of surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Surgically Induced Astigmatism	At baseline and 3 months postoperatively
Corneal Endothelial Cell Loss	Baseline and 3 months postoperatively
Change in Central Corneal Thickness	Baseline and 1 week
Anterior Chamber Inflammation	Baseline and 1 week
Anterior Chamber Inflammation	Baseline and 1 month

Collaborators and Investigators

• Sponsor: Iladevi Cataract and IOL Research Center
• Investigators: Principal Investigator: Abhay R Vasavada, MS, FRCS, Iladevi Cataract and IOL Research Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Anticipated): December 1, 2011
• Study Completion (Anticipated): December 1, 2011

Study Registration Dates

• First Submitted: June 29, 2011
• First Submitted That Met QC Criteria: June 29, 2011
• First Posted (Estimate): June 30, 2011

Study Record Updates

• Last Update Posted (Estimate): June 30, 2011
• Last Update Submitted That Met QC Criteria: June 29, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: Microcoaxial phacoemulsification, 1.8mm, 2.2mm
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: ICIRC-1.8 VS 2.2