Endothelial Cell Loss After Phacoemulsification Intra and Supracapsular (PERCEPOLIS)
Primary Purpose
Cataracts
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Subluxation
Divide and Conquer
Sponsored by
About this trial
This is an interventional supportive care trial for Cataracts focused on measuring Cataract surgery
Eligibility Criteria
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
Sites / Locations
- Chr Metz Thionville
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Subluxation
Divide and Conquer
Arm 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
Cataract nucleus is fragmented into 4 pieces then aspirated by ultrasonic vibration
Outcomes
Primary Outcome Measures
Main Outcome Measures: postoperative Endothelial cell loss of the central corneal
Secondary Outcome Measures
Full Information
NCT ID
NCT02535819
First Posted
June 30, 2015
Last Updated
April 12, 2019
Sponsor
Centre Hospitalier Régional Metz-Thionville
1. Study Identification
Unique Protocol Identification Number
NCT02535819
Brief Title
Endothelial Cell Loss After Phacoemulsification Intra and Supracapsular
Acronym
PERCEPOLIS
Official Title
Endothelial Cell Loss After Phacoemulsification Intra and Supracapsular
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
May 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Régional Metz-Thionville
4. Oversight
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataracts
Keywords
Cataract surgery
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
294 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Subluxation
Arm Type
Experimental
Arm 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
Arm Title
Divide and Conquer
Arm Type
Other
Arm Description
Cataract nucleus is fragmented into 4 pieces then aspirated by ultrasonic vibration
Intervention Type
Procedure
Intervention Name(s)
Subluxation
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Divide and Conquer
Intervention Description
Cataract nucleus is fragmented into 4 pieces then aspirated by ultrasonic vibration
Primary Outcome Measure Information:
Title
Main Outcome Measures: postoperative Endothelial cell loss of the central corneal
Time Frame
12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Marc PERONE, MD
Organizational Affiliation
CHR Metz-Thionville
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chr Metz Thionville
City
Metz
ZIP/Postal Code
57085
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
34732666
Citation
Perone JM, Ghetemme C, Zevering Y, Zaidi M, Ouamara N, Goetz C, Lhuillier L. Corneal Endothelial Cell Loss After Endocapsular and Supracapsular Phacoemulsification: The PERCEPOLIS Randomized Clinical Trial. Cornea. 2022 Jun 1;41(6):714-721. doi: 10.1097/ICO.0000000000002822. Epub 2021 Nov 2.
Results Reference
derived
Learn more about this trial
Endothelial Cell Loss After Phacoemulsification Intra and Supracapsular
We'll reach out to this number within 24 hrs