Outcomes of 3 Incision-size-dependent Phacoemulsification Systems

Study Overview
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Brief Summary
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The purpose of this study is to compare the outcomes of cataract surgery performed with three incision-size-dependent phacoemulsification systems (1.8, 2.2 and 3.0 mm).

Detailed Description
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It is generally the case that smaller corneal cataract surgical incisions are associated with more rapid wound healing, more stable corneal biomechanical properties and less surgically induced astigmatism (SIA). With the development of phacoemulsification and foldable intraocular lenses (IOL) during recent decades, the size of clear corneal incisions has been reduced from 3.2-mm (coaxial small incision) to 1.4-mm (bimanual micro incision). Micro incision cataract surgery (MICS), including bimanual and micro coaxial phacoemulsification, has attracted much interest recently, due to its safety and ease of learning. However, the superiority of coaxial micro incision cataract surgery as compared conventional coaxial cataract surgery is still not certain, because micro incision phacoemulsification may result in longer ultrasound time (UST), the use of more ultrasonic power and consequently higher endothelial cell loss (ECL). In our previous studies of the OZil Torsional phacoemulsification system (Infinity, Alcon), we reported that the safety and effectiveness of cataract surgery are influenced by many factors, including the blade used to create the incision, the phacoemulsification apparatus, and the IOL and mode of IOL delivery, which together constitute a surgical system, whose outcomes are restricted by the best performance of each component. Today, micro coaxial phacoemulsification is in wide use for cataract surgery, but the lower limits of incision size should be understood in the context of the various components of the surgical system. In this study, we compared the safety and efficacy of three different incision-size-dependent phacoemulsification systems, 1.8, 2.2 and 3.0 mm, and evaluated the relationship between incision size and SIA.

Official Title
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Clinical Evaluation of Three Incision-size-dependent Phacoemulsification Systems

Conditions
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Cataract

Intervention / Treatment
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* Procedure: phacoemulsification


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age between 55 and 85 years the presence of nuclear or cortex-nuclear cataract, grades 2.0 to 4.0 (Lens Opacities Classification System III) a transparent central cornea pupil dilating to >= 7 mm at the time of preoperative examination a preoperative central endothelial cell count of >= 1500 cells per square millimeter Exclusion Criteria: previous intraocular surgery glaucoma pseudoexfoliation uveitis high myopia diabetes mellitus

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 85 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group I<br>1.8-mm-incision-size phacoemulsification system | Procedure: phacoemulsification<br>* Cataract surgery performed with three incision-size-dependent phacoemulsification systems (1.8, 2.2 and 3.0 mm)<br>* Other names: Three incision-size(1.8, 2.2 and 3.0 mm);|
| Group II<br>2.2-mm-incision-size phacoemulsification system | Procedure: phacoemulsification<br>* Cataract surgery performed with three incision-size-dependent phacoemulsification systems (1.8, 2.2 and 3.0 mm)<br>* Other names: Three incision-size(1.8, 2.2 and 3.0 mm);|
| Group III<br>3.0-mm-incision-size phacoemulsification system | Procedure: phacoemulsification<br>* Cataract surgery performed with three incision-size-dependent phacoemulsification systems (1.8, 2.2 and 3.0 mm)<br>* Other names: Three incision-size(1.8, 2.2 and 3.0 mm);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central Cornea Endothelial Cell Loss | Central cornea endothelial cell loss was calculated on the basis of preoperative and postoperative endothelial cell density. | post-operative week 1, post-operative month 1, and post-operative month 3 | 
| Surgically Induced Astigmatism | Corneal astigmatism was measured using an eye scanner (Pentacam; Oculus, Wetzlar, Germany), and the SIA was calculated at each postoperative visit using the following equation. | post-operative week 1, post-operative month 1, and post-operative month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best-corrected Visual Acuity | The best-corrected visual acuity (BCVA) was measured, using an ETDRS chart and auto-refraction as refined by an ophthalmologist, preoperatively and at postoperative 1 day, 1 week, 1 month and 3 months. | post-operative week 1, post-operative month 1, and post-operative month 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cataract