Comparison the Topical Anesthesia and Retrobulbar Anesthesia for 27-gauge Vitrectomy for Vitreous Floaters

February 8, 2017 updated by: Lin Zhong

Routine anesthesia methods for vitrectomy surgery include retrobulbar and peribulbar anesthesia. However, both methods have potential complications that can vary from minor to severe.

Vitrectomy surgery for vitreous floaters is widely considered straighter forward than other vitreoretinal surgeries.

Hence, the investigators compared the effect of topical anesthesia (with eye drops) and retrobulbar anesthesia for 27-gauge par plana vitrectomy for symptomatic vitreous floaters.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

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.

Study Contact

  • Name: Zhong Lin, Doctor
  • Phone Number: +8613758475525

Study Locations

  • China
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325027
        • Recruiting
        • Ethics Committee of The Eye Hospital of Wenzhou Medical University
        • Contact:

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. patients who is going to undergo vitrectomy surgery for vitreous floaters
  2. age>18 years
  3. patients who are willing to participate in this study

Exclusion Criteria:

  1. patients who had vitrectomy surgery before
  2. patients who had penetrating ocular trauma before

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: vitrectomy under retrobulbar anesthesia
27-gauge vitrectomy for vitreous floaters under traditional retrobulbar anesthesia
Drug: vitrectomy under topical anesthesia [Proparacaine HCL (Alcaine®)]
to observe the anesthesia effect of topical anesthesia of 27-gauge vitrectomy for vitreous floaters
Other Names:
  • 0.5% proparacaine HCL (Alcaine®, Alcon, TX)
Experimental: vitrectomy under topical anesthesia
27-gauge vitrectomy for vitreous floaters under topical anesthesia
Drug: vitrectomy under topical anesthesia [Proparacaine HCL (Alcaine®)]
to observe the anesthesia effect of topical anesthesia of 27-gauge vitrectomy for vitreous floaters
Other Names:
  • 0.5% proparacaine HCL (Alcaine®, Alcon, TX)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visual Analogue Pain Scale
Time Frame: 2 hour post-operation
2 hour post-operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lin Zhong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2016

Primary Completion (Anticipated)

March 1, 2017

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

January 28, 2017

First Submitted That Met QC Criteria

February 8, 2017

First Posted (Estimate)

February 9, 2017

Study Record Updates

Last Update Posted (Estimate)

February 9, 2017

Last Update Submitted That Met QC Criteria

February 8, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KYQD131101-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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