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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

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.

Condition or disease Intervention/treatment
Cataract Procedure: Subluxation Procedure: Divide and conquer

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).

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Study Type : Observational
Actual Enrollment : 96 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Central Corneal Thickness Assessment After Phacoemulsification: Subluxation Versus Divide-and-Conquer
Actual Study Start Date : January 2015
Actual Primary Completion Date : July 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract Edema

Group/Cohort Intervention/treatment
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
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
Procedure: Divide and conquer
Cataract nucleus is fragmented into 4 pieces then aspirated by ultrasonic vibration




Primary Outcome Measures :
  1. Corneal edema preoperative [ Time Frame: Day 1 ]
    Central corneal thickness measurements were taken preoperatively


Secondary Outcome Measures :
  1. Corneal edema postoperative [ Time Frame: Day 4 ]
    Central corneal thickness measurements were taken postoperative day 4



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients underwent phacoemulsification cataract surgery over a 6-month period.
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
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Responsible Party: Centre Hospitalier Régional Metz-Thionville
ClinicalTrials.gov Identifier: NCT03689270    
Other Study ID Numbers: 2015-12Obs-CHMRT
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Régional Metz-Thionville:
subluxation
Divide and conquer
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases