- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03266406
Effect of Hyaluronidase on Intraocular Pressure
August 28, 2017 updated by: Eman Yassin Ahmed, Assiut University
Effect of Hyaluronidase on Intraocular Pressure After Retrobulbar Anaesthesia During Cataract Surgery
The aim of this study is to evaluate effect of retrobulbar local anaesthesia after addition of hyaluronidase on IOP during cataract surgery
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Effect of hyaluronidase on IOP
|
4ml of retrobulbar LA with addition of 15IU/ml hyaluronidase to 2% lidocaine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
reduction in IOP
Time Frame: within 10minutes
|
reduction of complications of high IOP during surgery
|
within 10minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
September 1, 2017
Primary Completion (Anticipated)
September 1, 2018
Study Completion (Anticipated)
October 1, 2018
Study Registration Dates
First Submitted
August 28, 2017
First Submitted That Met QC Criteria
August 28, 2017
First Posted (Actual)
August 30, 2017
Study Record Updates
Last Update Posted (Actual)
August 30, 2017
Last Update Submitted That Met QC Criteria
August 28, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- effect of hyaluronidase on IOP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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