NCT03266406

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 30, 2017

Completed
2 days until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

August 30, 2017

Status Verified

August 1, 2017

Enrollment Period

1 year

First QC Date

August 28, 2017

Last Update Submit

August 28, 2017

Conditions

Intraocular Pressure Low

Outcome Measures

Primary Outcomes (1)

  • reduction in IOP

    reduction of complications of high IOP during surgery

    within 10minutes

Study Arms (1)

Effect of hyaluronidase on IOP

EXPERIMENTAL
Drug: Hyaluronidase

Interventions

HyaluronidaseDRUG

4ml of retrobulbar LA with addition of 15IU/ml hyaluronidase to 2% lidocaine

Effect of hyaluronidase on IOP

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients above the age of 50 years. 2-Patients with age related cataract. 3-Normal IOP.

You may not qualify if:

  • History 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Ocular Hypotension

Interventions

Hyaluronoglucosaminidase

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Glycoside HydrolasesHydrolasesEnzymesEnzymes and CoenzymesPolysaccharide-LyasesCarbon-Oxygen LyasesLyases

Central Study Contacts

Eman Yassin

CONTACT

00201004686028emanyassin08@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 28, 2017

First Posted

August 30, 2017

Study Start

September 1, 2017

Primary Completion

September 1, 2018

Study Completion

October 1, 2018

Last Updated

August 30, 2017

Record last verified: 2017-08