Endothelial Cell Loss After Phacoemulsification Intra and Supracapsular (PERCEPOLIS)

Centre Hospitalier Régional Metz-Thionville

Status: Completed

Conditions: Cataracts

Treatments: Procedure: Subluxation; Procedure: Divide and Conquer

Study type: Interventional

Funder types: Other

Identifiers

NCT02535819

2015-01-CHRMT

2015-A00789-40 (Other Identifier)

Details and patient eligibility

About

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)

Enrollment: 294 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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294 participants in 2 patient groups

Subluxation

Experimental group

Description:

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

Treatment:

Procedure: Subluxation

Divide and Conquer

Other group

Description:

Cataract nucleus is fragmented into 4 pieces then aspirated by ultrasonic vibration

Treatment:

Procedure: Divide and Conquer