NCT06830070

Brief Summary

Subtenonal anesthesia is a well-known technique of local anesthesia for patients undergoing pars plana vitrectomies. It was described to be efficient with respect to anesthesia of the eye and it showed less risks compared to retrobulbar or parabulbar anesthesia. Purpose of the study is to assess subjective pain scores of patients, that underwent vitrectomy with subtenonal anesthesia.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

December 13, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 11, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 17, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

February 20, 2025

Status Verified

February 1, 2025

Enrollment Period

1.5 years

First QC Date

February 11, 2025

Last Update Submit

February 18, 2025

Conditions

Epiretinal MembranesRetinal DetachmentFull Thickness Macular Hole

Keywords

subjective pain scoreVASsubtenonal anesthesia

Outcome Measures

Primary Outcomes (1)

  • subjective pain score during surgery

    subjective pain score during surgery are assessed with Visual Analogue Scale from 0 to 10. The value of 0 represents no pain and the value of 10 represents the highest pain that can be imagined.

    assessed within 24 hours sfter surgery

Study Arms (2)

vitreoretinal surface diseases

patients with the indications epiretinal membranes or full thickness macular holes are belonging to the Group of vitreoretnal surface diseases

Other: subjective pain score assessment

retinal detachment

patients with the indication retinal detachment are belonging to this group

Other: subjective pain score assessment

Interventions

subjective pain score assessmentOTHER

a questionnaire assessing subjective pain during surgery, using the Visual Analogue Scale with values from 0 to 10

retinal detachmentvitreoretinal surface diseases

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients having undergone vitrectomy in subtenon´s anesthesia

You may qualify if:

  • Vitrectomy with subtenonal anesthesia in the time-period from 1.12.2022 to 31.8.2023
  • Indication for surgery: retinal detachment, epiretinal membrane, or full thickness macular hole
  • Questionnaire for subtenonal anesthesia was already answered by the patients
  • Age 18 and older

You may not qualify if:

  • Any of the following will exclude a subject from the study:
  • Surgery in general anesthesia
  • Questionnaire missing or incomplete

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vienna Institute for Research in Ocular Surgery

Vienna, 1140, Austria

Location

Related Publications (3)

  • El-Hindy N, Johnston RL, Jaycock P, Eke T, Braga AJ, Tole DM, Galloway P, Sparrow JM; UK EPR user group. The Cataract National Dataset Electronic Multi-centre Audit of 55,567 operations: anaesthetic techniques and complications. Eye (Lond). 2009 Jan;23(1):50-5. doi: 10.1038/sj.eye.6703031. Epub 2008 Mar 14.

    PMID: 18344970BACKGROUND

  • Lai MM, Lai JC, Lee WH, Huang JJ, Patel S, Ying HS, Melia M, Haller JA, Handa JT. Comparison of retrobulbar and sub-Tenon's capsule injection of local anesthetic in vitreoretinal surgery. Ophthalmology. 2005 Apr;112(4):574-9. doi: 10.1016/j.ophtha.2004.10.043.

    PMID: 15808246BACKGROUND

  • Friedberg MA, Spellman FA, Pilkerton AR, Perraut LE Jr, Stephens RF. An alternative technique of local anesthesia for vitreoretinal surgery. Arch Ophthalmol. 1991 Nov;109(11):1615-6. doi: 10.1001/archopht.1991.01080110153055.

    PMID: 1845110BACKGROUND

MeSH Terms

Conditions

Epiretinal MembraneRetinal Detachment

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Officials

  • Oliver Findl

    Vienna Institute for Research in Ocular Surgery

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of department

Study Record Dates

First Submitted

February 11, 2025

First Posted

February 17, 2025

Study Start

December 13, 2023

Primary Completion

May 31, 2025

Study Completion

May 31, 2025

Last Updated

February 20, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)