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

• Sponsor: Iladevi Cataract and IOL Research Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01385878
• Collaborator: (none)
• Enrollment: 110
• Location: 1
• Arms: 2
• Duration (Months): 11
• Patients Per Site Per Month: 10

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Procedure: Microcoaxial Phacoemulsification; Procedure: Microcoaxial Phacoemulsification; Procedure: Microcoaxial Phacoemulsification; Procedure: Microcoaxial Phacoemulsification	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 110 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Intraoperative Performance & Postoperative Outcomes Following Phacoemulsification With 1.8 & 2.2mm Incision: Randomized Clinical Trial
• Study Start Date: Jan 1, 2011
• Anticipated Primary Completion Date: Dec 1, 2011
• Anticipated Study Completion Date: Dec 1, 2011

Arms and Interventions

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
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

Outcome Measures

Primary Outcome Measures

1. Ingress of Trypan blue from the Ocular Surface into the Anterior Chamber [Immediately at the end of surgery]

   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

1. Surgically Induced Astigmatism [At baseline and 3 months postoperatively]

2. Corneal Endothelial Cell Loss [Baseline and 3 months postoperatively]

3. Change in Central Corneal Thickness [Baseline and 1 week]

4. Anterior Chamber Inflammation [Baseline and 1 week]

5. Anterior Chamber Inflammation [Baseline and 1 month]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Iladevi Cataract & IOL Research Centre	Ahmedabad	Gujarat	India	380009

Sponsors and Collaborators

• Iladevi Cataract and IOL Research Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

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.

• ClinicalTrials.gov Identifier: NCT01385878
• Other Study ID Numbers: ICIRC-1.8 VS 2.2
• First Posted: Jun 30, 2011
• Last Update Posted: Jun 30, 2011
• Last Verified: Jun 1, 2011

• Keywords provided by , ,: Microcoaxial phacoemulsification, 1.8mm, 2.2mm
• Additional relevant MeSH terms: Cataract

Study Results

No Results Posted as of Jun 30, 2011