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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01385878
• Other study ID #: ICIRC-1.8 VS 2.2
• Status: Unknown status
• Phase: N/A
• First received: June 29, 2011
• Last updated: June 29, 2011
• Start date: January 2011
• Est. completion date: December 2011

Study information

• Verified date: June 2011
• Source: Iladevi Cataract and IOL Research Center
• Contact: Abhay R Vasavada, MS,FRCS
• Phone: 91-79-27490909
• Email: icirc[@]abhayvasavada.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 110
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Intervention

Procedure:
• Microcoaxial Phacoemulsification
Phacoemulsification through small clear corneal incision
• Microcoaxial Phacoemulsification
Phacoemulsification through clear corneal incision
• Microcoaxial Phacoemulsification
Microcoaxial Phacoemulsification through 1.8mm incision
• Microcoaxial Phacoemulsification
Microcoaxial phacoemulsification through 2.2mm incision

Locations

Country	Name	City	State
India	Iladevi Cataract & IOL Research Centre	Ahmedabad	Gujarat

Sponsors (1)

Lead Sponsor	Collaborator
Iladevi Cataract and IOL Research Center

Country where clinical trial is conducted

India, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Surgically Induced Astigmatism		At baseline and 3 months postoperatively
Secondary	Corneal Endothelial Cell Loss		Baseline and 3 months postoperatively
Secondary	Change in Central Corneal Thickness		Baseline and 1 week
Secondary	Anterior Chamber Inflammation		Baseline and 1 week
Secondary	Anterior Chamber Inflammation		Baseline and 1 month