NCT01019018

Brief Summary

The purpose of this study is to compare the efficacy of olive tip cannula to the standard Steven's cannula in performing subtenon's anesthesia for patients undergoing cataract surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2009

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

November 1, 2009

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2009

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 25, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

October 21, 2021

Status Verified

November 1, 2009

Enrollment Period

1.4 years

First QC Date

November 17, 2009

Last Update Submit

October 14, 2021

Conditions

Cataract

Keywords

subtenon block

Outcome Measures

Primary Outcomes (1)

  • Measurement of Akinesia score

    10 minutes after the block

Secondary Outcomes (1)

  • Surgeon satisfactions score

    At the end of the procedure

Study Arms (2)

Stevens cannula

ACTIVE COMPARATOR

Subtenon with stevens cannula

Device: subtenon block

Olive tip

EXPERIMENTAL

Olive tip group

Device: subtenon block

Interventions

subtenon blockDEVICE

subtenon block with stevens cannula

Stevens cannula

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient undergoing cataract extraction procedure under local anesthesia

You may not qualify if:

  • Patients allergic to local anesthetic solutions.
  • Presence local sepsis,
  • Previous retinal or strabismus surgery in the same eye.
  • Orbital abnormalities
  • Previous subtenon's block in the same quadrant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

king Khaled Eye Specialist hospital

Riyadh, 11462, Saudi Arabia

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2009

First Posted

November 25, 2009

Study Start

November 1, 2009

Primary Completion

April 1, 2011

Study Completion

October 1, 2011

Last Updated

October 21, 2021

Record last verified: 2009-11

Locations

SA(1)