NCT03049163

Brief Summary

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.

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 not_applicable

Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable

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

October 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 9, 2017

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

February 9, 2017

Status Verified

February 1, 2017

Enrollment Period

5 months

First QC Date

January 28, 2017

Last Update Submit

February 8, 2017

Conditions

Perioperative Pain Experiences

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue Pain Scale

    2 hour post-operation

Study Arms (2)

vitrectomy under retrobulbar anesthesia

OTHER

27-gauge vitrectomy for vitreous floaters under traditional retrobulbar anesthesia

Drug: vitrectomy under topical anesthesia [Proparacaine HCL (Alcaine®)]

vitrectomy under topical anesthesia

EXPERIMENTAL

27-gauge vitrectomy for vitreous floaters under topical anesthesia

Drug: vitrectomy under topical anesthesia [Proparacaine HCL (Alcaine®)]

Interventions

vitrectomy under topical anesthesia [Proparacaine HCL (Alcaine®)]DRUG

to observe the anesthesia effect of topical anesthesia of 27-gauge vitrectomy for vitreous floaters

Also known as: 0.5% proparacaine HCL (Alcaine®, Alcon, TX)
vitrectomy under retrobulbar anesthesiavitrectomy under topical anesthesia

Eligibility Criteria

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

You may qualify if:

  • patients who is going to undergo vitrectomy surgery for vitreous floaters
  • age\>18 years
  • patients who are willing to participate in this study

You may not qualify if:

  • patients who had vitrectomy surgery before
  • patients who had penetrating ocular trauma before

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ethics Committee of The Eye Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325027, China

RECRUITING

Related Publications (2)

  • Wu RH, Zhang R, Lin Z, Liang QH, Moonasar N. A comparison between topical and retrobulbar anesthesia in 27-gauge vitrectomy for vitreous floaters: a randomized controlled trial. BMC Ophthalmol. 2018 Jul 7;18(1):164. doi: 10.1186/s12886-018-0838-7.

    PMID: 29981573DERIVED

  • Lin Z, Zhang R, Liang QH, Lin K, Xiao YS, Moonasar N, Wu RH. Surgical Outcomes of 27-Gauge Pars PLana Vitrectomy for Symptomatic Vitreous Floaters. J Ophthalmol. 2017;2017:5496298. doi: 10.1155/2017/5496298. Epub 2017 Nov 29.

    PMID: 29318039DERIVED

MeSH Terms

Interventions

proxymetacainemethylacetylene

Central Study Contacts

Zhong Lin, Doctor

CONTACT

+8613758475525

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

January 28, 2017

First Posted

February 9, 2017

Study Start

October 1, 2016

Primary Completion

March 1, 2017

Study Completion

June 1, 2017

Last Updated

February 9, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)