Endothelial Cell Loss After Phacoemulsification Intra and Supracapsular

Not Applicable

Completed

• Conditions: Cataracts
• Interventions: Procedure: Divide and Conquer; Procedure: Subluxation

• Registration Number: NCT02535819
• Lead Sponsor: Centre Hospitalier Régional Metz-Thionville

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-30
• Study First Submitted QC: 2015-08-26
• Study First Posted: 2015-08-31
• Status Verified: 2017-09
• Primary Completion: 2017-09
• Study Completion: 2018-05
• Last Update Submitted: 2019-04-12
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 294

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Divide and Conquer	Divide and Conquer	Cataract nucleus is fragmented into 4 pieces then aspirated by ultrasonic vibration
Subluxation	Subluxation	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

Primary Outcome Measures

Name	Time	Method
Main Outcome Measures: postoperative Endothelial cell loss of the central corneal	12 month

Trial Locations

Locations (1)

Chr Metz Thionville; 🇫🇷 Metz, France