Clinical trial NCT01385878: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Cataract
Keywords: Microcoaxial phacoemulsification, 1.8mm, 2.2mm
Lead sponsor: Iladevi Cataract and IOL Research Center
Sponsor class: OTHER
First posted: 2011-06-30
Enrollment: 110
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Ingress of Trypan blue from the Ocular Surface into the Anterior Chamber
timeFrame: Immediately at the end of surgery
Secondary outcomes:
measure: Surgically Induced Astigmatism
timeFrame: At baseline and 3 months postoperatively
measure: Corneal Endothelial Cell Loss
timeFrame: Baseline and 3 months postoperatively
measure: Change in Central Corneal Thickness
timeFrame: Baseline and 1 week
measure: Anterior Chamber Inflammation
timeFrame: Baseline and 1 week
measure: Anterior Chamber Inflammation
timeFrame: Baseline and 1 month
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: Iladevi Cataract & IOL Research Centre
state: Gujarat
Study officials:
affiliation: Iladevi Cataract and IOL Research Center
name: Abhay R Vasavada, MS, FRCS
role: PRINCIPAL_INVESTIGATOR
References:
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.