Back to resultsEffect of Hyaluronidase on Intraocular Pressure
Primary Purpose
Intraocular Pressure Low
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hyaluronidase
Sponsored by
About this trial
This is an interventional diagnostic trial for Intraocular Pressure Low
Eligibility Criteria
Inclusion Criteria:
- 1-Patients above the age of 50 years. 2-Patients with age related cataract. 3-Normal IOP.
Exclusion Criteria:
- 1History of trauma. 2-Patients with glaucoma. 3-Previous ocular surgery. 4-Patients with other ocular pathology. 5-Uncontrolled diabetes or hypertension. 6-hypersensitivity to lignocaine. 7-Uncooperative or epileptic patients.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Effect of hyaluronidase on IOP
Arm Description
Outcomes
Primary Outcome Measures
reduction in IOP
reduction of complications of high IOP during surgery
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03266406
Brief Title
Effect of Hyaluronidase on Intraocular Pressure
Official Title
Effect of Hyaluronidase on Intraocular Pressure After Retrobulbar Anaesthesia During Cataract Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 2017 (Anticipated)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
October 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of this study is to evaluate effect of retrobulbar local anaesthesia after addition of hyaluronidase on IOP during cataract surgery
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraocular Pressure Low
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Effect of hyaluronidase on IOP
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Hyaluronidase
Intervention Description
4ml of retrobulbar LA with addition of 15IU/ml hyaluronidase to 2% lidocaine
Primary Outcome Measure Information:
Title
reduction in IOP
Description
reduction of complications of high IOP during surgery
Time Frame
within 10minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1-Patients above the age of 50 years. 2-Patients with age related cataract. 3-Normal IOP.
Exclusion Criteria:
1History of trauma. 2-Patients with glaucoma. 3-Previous ocular surgery. 4-Patients with other ocular pathology. 5-Uncontrolled diabetes or hypertension. 6-hypersensitivity to lignocaine. 7-Uncooperative or epileptic patients.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eman Yassin
Phone
00201004686028
Email
emanyassin08@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Effect of Hyaluronidase on Intraocular Pressure
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