Effect of Hyaluronidase on Intraocular Pressure | NCT03266406

Studies
Effect of Hyaluronidase on Intraocular Pressure

NCT03266406

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Aug 30, 2017Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Intraocular Pressure Low

Interventions

Hyaluronidase

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2017Estimated

Primary Completion Date

Sep 2018Estimated

Completion Date

Oct 2018Estimated

First Submitted Date

Aug 28, 2017

First Submission Date that Met QC Criteria

Aug 28, 2017

First Posted Date

Aug 30, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 28, 2017

Last Update Posted Date

Aug 30, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is to evaluate effect of retrobulbar local anaesthesia after addition of hyaluronidase on IOP during cataract surgery

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Effect of hyaluronidase on IOP	Experimental		Drug: Hyaluronidase

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hyaluronidase	Drug	4ml of retrobulbar LA with addition of 15IU/ml hyaluronidase to 2% lidocaine	Effect of hyaluronidase on IOP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
reduction in IOP	reduction of complications of high IOP during surgery	within 10minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Eman Yassin	Contact	00201004686028		emanyassin08@gmail.com

Overall Officials

Not provided

Locations

Not provided

ID	Term
D015814	Ocular Hypotension

ID	Term
D005128	Eye Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D006821	Hyaluronoglucosaminidase

Ancestor Terms

ID	Term
D006026	Glycoside Hydrolases
D006867	Hydrolases
D004798	Enzymes
D045762	Enzymes and Coenzymes

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Browse Branches

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