Endothelial Cell Loss After Phacoemulsification Intra and Supracapsular

Cataracts Clinical Trial

— PERCEPOLIS  

Official title:

Endothelial Cell Loss After Phacoemulsification Intra and Supracapsular

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02535819
• Other study ID #: 2015-01-CHRMT
• Secondary ID: 2015-A00789-40
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: May 2018

Study information

• Verified date: September 2017
• Source: Centre Hospitalier Régional Metz-Thionville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 294
• Est. completion date: May 2018
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Cataracts

Intervention

Procedure:
• 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
• Divide and Conquer
Cataract nucleus is fragmented into 4 pieces then aspirated by ultrasonic vibration

Locations

Country	Name	City	State
France	Chr Metz Thionville	Metz

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional Metz-Thionville

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Main Outcome Measures: postoperative Endothelial cell loss of the central corneal		12 month