Outcomes Following Phacoemulsification With 1.8 & 2.2mm Incision: Randomized Clinical Trial
- Conditions
- Cataract
- Interventions
- Procedure: Microcoaxial Phacoemulsification
- Registration Number
- NCT01385878
- Lead Sponsor
- Iladevi Cataract and IOL Research Center
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 110
Uncomplicated age related cataracts, NO grade II III, IV (LOCS III classification)
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Phacoemulsification with 1.8mm incision Microcoaxial Phacoemulsification Microcoaxial phacoemulsification was performed using a 1.8mm clear corneal incision Phacoemulsification with 2.2mm incisi Microcoaxial Phacoemulsification Microcoaxial phacoemulsificaiton will be performed through 2.2mm incision
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 month
Trial Locations
- Locations (1)
Iladevi Cataract & IOL Research Centre
🇮🇳Ahmedabad, Gujarat, India