- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07654387
Divide and Conquer With Debulking in Management of Rocky Hard Cataract
The management of nucleus may be challenging in rocky hard cataracts. Hard cataracts are difficult to fragment, and the excessive energy required to emulsify the hard nucleus can result in complications such as corneal edema, inflammation, wound burn, posterior capsular rupture, and zonular dialysis. different surgical techniques are used for the management of hard cataracts, with their advantages and limitations. Divide and conquer with debulking is a new technique for management of rocky hard cataract.
In this research we assess its safety comparing it with standard divide and conquer technique.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The management of nucleus may be challenging in rocky hard cataracts. Hard cataracts are difficult to fragment, and the excessive energy required to emulsify the hard nucleus can result in complications such as corneal edema, inflammation, wound burn, posterior capsular rupture, and zonular dialysis. different surgical techniques are used for the management of hard cataracts, with their advantages and limitations. Divide and conquer with debulking is a new technique for management of rocky hard cataract.
In this research we assess its safety comparing it with standard divide and conquer technique.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hany Mahmoud
- Phone Number: 01024368111
- Email: drhanymahmoud@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- adults with rocky hard cataract
Exclusion Criteria:
- patients with abnormal endothelial cell count.
- patients with glaucoma.
- patients with retinal problems.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: standard divide and conquer
patients with rocky hard cataract will undergo standard divide and conquer technique
|
phacoemulsification either by standard divide and conquer or divide and conquer with debulking.
|
|
Experimental: divide and conquer with debulking
patients with rocky hard cataract will undergo divide and conquer with debulking technique
|
phacoemulsification either by standard divide and conquer or divide and conquer with debulking.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
endothelial cell count
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Soh-Med-26-5-3PD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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