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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cataract

Intervention / Treatment
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* Procedure: Microcoaxial Phacoemulsification
* Procedure: Microcoaxial Phacoemulsification
* Procedure: Microcoaxial Phacoemulsification
* Procedure: Microcoaxial Phacoemulsification


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Phacoemulsification with 1.8mm incision<br>Microcoaxial phacoemulsification was performed using a 1.8mm clear corneal incision | Procedure: Microcoaxial Phacoemulsification<br>* Phacoemulsification through small clear corneal incision<br>Procedure: Microcoaxial Phacoemulsification<br>* Phacoemulsification through clear corneal incision<br>Procedure: Microcoaxial Phacoemulsification<br>* Microcoaxial Phacoemulsification through 1.8mm incision<br>|
| Active Comparator: Phacoemulsification with 2.2mm incisi<br>Microcoaxial phacoemulsificaiton will be performed through 2.2mm incision | Procedure: Microcoaxial Phacoemulsification<br>* Phacoemulsification through small clear corneal incision<br>Procedure: Microcoaxial Phacoemulsification<br>* Phacoemulsification through clear corneal incision<br>Procedure: Microcoaxial Phacoemulsification<br>* Microcoaxial Phacoemulsification through 1.8mm incision<br>Procedure: Microcoaxial Phacoemulsification<br>* Microcoaxial phacoemulsification through 2.2mm incision<br>|

What is the study measuring?
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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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microcoaxial phacoemulsification, 1.8mm, 2.2mm