Endothelial Cell Loss After Phacoemulsification Intra and Supracapsular

Study Overview
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Brief Summary
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Cataract is the clouding of the lens of the eye, which initially prevents clear vision and eventually progresses to blindness if left untreated. Cataract remains the leading cause of blindness and an important cause of visual impairment across the globe. Cataract surgery by ultrasonic phacoemulsification is the most common surgery practiced in France (600 000/year) Two sub-categories of phacoemulsification coexist : Endocapsulars techniques represented by Divide-and-Conquer and Phaco-Chop ; and Supracapsular techniques mainly represented by Subluxation (similar to Tilt-and-Tumble) The corneal endothelium plays an important role in maintaining the dehydrated state and the transparency of the cornea. Some degree of endothelial cell loss invariably occurs in all types of cataract surgery but the amount of endothelial cell loss may varies with the type of surgical technique The aim of the study is to evaluate the density of the central corneal endothelial cells before and after cataract surgery comparing two phacoemulsification techniques (Divide-and-Conquer vs Subluxation)

Official Title
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Endothelial Cell Loss After Phacoemulsification Intra and Supracapsular

Conditions
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Cataracts

Intervention / Treatment
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* Procedure: Subluxation
* Procedure: Divide and Conquer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female aged ≥ 18 years Patients undergoing cataract surgery Visual acuity Monoyer scale <6/10e (< +0.2 logMar) Nuclear, cortical and posterior subcapsular cataract with normal density to severe in the LOCSIII classification Exclusion Criteria: insulin-dependent diabetes and /or diabetic retinopathy corneal disease: keratitis, dystrophy, corneal degeneration Any disease of intraocular pressure Any disease of the anterior segment Low preoperative endothelial cell density < 1500 c/mm² Combined surgery (cataract + corneal transplant, cataract + glaucoma surgery, cataract +vitrectomy ...) Risk factors for surgical per-operative complication Pregnancy, lactation Ward of court Patient not covered by the Social Security scheme

Ages Eligible for Study
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Minimum Age: 18 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subluxation<br>Nucleus is hydrodissected until it lilts above the capsular bag, rotated to face the incision then tumbled and emulsification continues from the opposite equator outside in until complete | Procedure: Subluxation<br>* One pole of The nucleus is hydrodissected until it lilts above the capsular bag. The tilted nucleus is rotated to face the incision and remaining half nucleus is then tumbled and emulsification continues from the opposite equator outside in until complete<br>|
| Other: Divide and Conquer<br>Cataract nucleus is fragmented into 4 pieces then aspirated by ultrasonic vibration | Procedure: Divide and Conquer<br>* Cataract nucleus is fragmented into 4 pieces then aspirated by ultrasonic vibration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Main Outcome Measures: postoperative Endothelial cell loss of the central corneal |  | 12 month | 

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