NCT01417572

Brief Summary

The purpose of this study is to evaluate the effect of topical lidocaine in scleral buckling surgery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 1, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

August 9, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 16, 2011

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

August 16, 2011

Status Verified

January 1, 2010

Enrollment Period

7 months

First QC Date

August 9, 2011

Last Update Submit

August 15, 2011

Conditions

Retinal Detachment

Outcome Measures

Primary Outcomes (5)

  • intraoperative heart rate measurement

    6 month

  • decrease in pain and nausea,vomiting after surgery

    6 month

  • decrease in ocr after application of topical lidocaine

    6 month

  • postoperative nausea and vommitting

    6 month

  • postoperative pain

    6 month

Study Arms (1)

lidocaine

EXPERIMENTAL
Drug: lidocaine

Interventions

lidocaineDRUG

to evaluate the effect of lidocaine on oculocardiac reflex during the surgery

lidocaine

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Retinal detachment
  • Retinal tear less than 3 hour clock

You may not qualify if:

  • Vitreous hemorrhage
  • Proliferative vitreoretinopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Isfahan University of Medical Sciences

Isfahan, Isfahan, 7864329800, Iran

RECRUITING

MeSH Terms

Conditions

Retinal Detachment

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Central Study Contacts

Amin Masjedi, MD

CONTACT

+983112211915Masjedi1827@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 9, 2011

First Posted

August 16, 2011

Study Start

January 1, 2010

Primary Completion

August 1, 2010

Study Completion

September 1, 2011

Last Updated

August 16, 2011

Record last verified: 2010-01

Locations

IR(1)