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Corneal Edema After Phacoemulsification (COPHA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03689270
Recruitment Status : Completed
First Posted : September 28, 2018
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Régional Metz-Thionville

Tracking Information
First Submitted Date September 25, 2018
First Posted Date September 28, 2018
Last Update Posted Date September 28, 2018
Actual Study Start Date January 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 26, 2018)
Corneal edema preoperative [ Time Frame: Day 1 ]
Central corneal thickness measurements were taken preoperatively
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: September 26, 2018)
Corneal edema postoperative [ Time Frame: Day 4 ]
Central corneal thickness measurements were taken postoperative day 4
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Corneal Edema After Phacoemulsification
Official Title Central Corneal Thickness Assessment After Phacoemulsification: Subluxation Versus Divide-and-Conquer
Brief Summary To compare the impact of two phacoemulsification techniques (subluxation versus divide-and-conquer) on postoperative corneal edema at postoperative hour 1 and day 4.
Detailed Description

Phacoemulsification is the procedure of choice for most surgeons performing cataract surgery. Alternative techniques have been in development over the last twenty years, with the hope of optimizing operating times, total ultrasound energy used, patient safety, patient satisfaction and visual recovery associated with cataract surgery.

Divide-and conquer is the parent nucleofracture technique.The subluxation technique is a newer technique that is less frequently used because of an increased risk of corneal endothelium damage.

The aim of this comparative study was to evaluate corneal edema immediately after surgery performed with the subluxation technique versus divide-and-conquer. Corneal edema was determined by measuring central corneal thickness (CCT).

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients underwent phacoemulsification cataract surgery over a 6-month period.
Condition Cataract
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.
  • Procedure: Divide and conquer
    Cataract nucleus is fragmented into 4 pieces then aspirated by ultrasonic vibration
Study Groups/Cohorts
  • 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
    Intervention: Procedure: Subluxation
  • Divide and Conquer
    Cataract nucleus is fragmented into 4 pieces then aspirated by ultrasonic vibration
    Intervention: Procedure: Divide and conquer
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 26, 2018)
96
Original Actual Enrollment Same as current
Actual Study Completion Date December 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • The presence of a senile cataract with equivalent grades and history of visual acuity regression
  • Informed written consent

Exclusion Criteria:

  • Patients with total white cataract
  • With history of ocular surgery and other eye diseases (corneal pathology, uveitis, glaucoma)
  • With systemic diseases with the potential to affect vision
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03689270
Other Study ID Numbers 2015-12Obs-CHMRT
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Centre Hospitalier Régional Metz-Thionville
Study Sponsor Centre Hospitalier Régional Metz-Thionville
Collaborators Not Provided
Investigators Not Provided
PRS Account Centre Hospitalier Régional Metz-Thionville
Verification Date August 2018