Overview

This trial is active, not recruiting.

Condition cataracts
Treatments subluxation, divide and conquer
Sponsor Centre Hospitalier Régional Metz-Thionville
Start date June 2015
End date September 2017
Trial size 294 participants
Trial identifier NCT02535819, 2015-01-CHRMT, 2015-A00789-40

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)

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
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
subluxation
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
(Other)
Cataract nucleus is fragmented into 4 pieces then aspirated by ultrasonic vibration
divide and conquer
Cataract nucleus is fragmented into 4 pieces then aspirated by ultrasonic vibration

Primary Outcomes

Measure
Main Outcome Measures: postoperative Endothelial cell loss of the central corneal
time frame: 12 month

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Endothelial Cell Loss After Phacoemulsification Intra and Supracapsular
Principal investigator Jean-Marc PERONE, MD
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Centre Hospitalier Régional Metz-Thionville.