ClinicalTrials.gg
Active, not recruitingNCT06830070Updated Feb 20, 2025

Subjective Pain Scoring for Subtenonal Anesthesia During Vitrectomy

An observational study in Epiretinal Membranes, Retinal Detachment and Full Thickness Macular Hole, sponsored by Prim. Prof. Dr. Oliver Findl, MBA. Active, not recruiting at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-20.

Sponsored by Prim. Prof. Dr. Oliver Findl, MBA · Observational

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 5 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
70
Ages
18 Years and older
Sex
All
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Study 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.

Read the detailed description

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. Subjective pain scores of patients, that underwent vitrectomy with subtenonal anesthesia, are probably different among patients with excessive indentation of the bulbus for retinal detachment repair, compared to patients undergoing vitrectomy with membrane peeling for epiretinal membranes or full thickness macular holes. Purpose of the study is to assess subjective pain scores of patients, that underwent vitrectomy with subtenonal anesthesia.

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Conditions studied

  • Epiretinal Membranes
  • Retinal Detachment
  • Full Thickness Macular Hole

Keywords

  • subjective pain score
  • VAS
  • subtenonal anesthesia
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In context

Epiretinal Membrane

130 studies on the registry are indexed under Epiretinal Membrane; 18 are open to participants now.

This study's enrollment of 70 is above the median of 60 across 48 observational studies indexed under Epiretinal Membrane.

Browse Epiretinal Membrane studies →

Lead sponsor

Prim. Prof. Dr. Oliver Findl, MBA is the lead sponsor of 39 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients having undergone vitrectomy in subtenon´s anesthesia

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion criteria

Any of the following will exclude a subject from the study:

  • Surgery in general anesthesia
  • Questionnaire missing or incomplete
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
70 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Othersubjective pain score assessment

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

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What researchers measure

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.

    Time frame: assessed within 24 hours sfter surgery

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Study locations

1 site
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References and documents

Publications

  • 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. PubMed 18344970 ↗
  • 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. PubMed 15808246 ↗
  • 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. PubMed 1845110 ↗

Individual participant data

Plan to share: No

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Dec 2023 (actual). Primary completion is estimated for May 2025, 17 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 11, 2025
First posted
Feb 17, 2025
StartActual
Dec 13, 2023
Primary completionEst.
May 31, 2025
CompletionEst.
May 31, 2025
Last update
Feb 20, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06830070
Lead sponsor
Prim. Prof. Dr. Oliver Findl, MBA
Responsible party
Prim. Prof. Dr. Oliver Findl, MBA (Head of department, Vienna Institute for Research in Ocular Surgery) — Sponsor-investigator
First posted
Feb 17, 2025
Start date
Dec 13, 2023
Primary completion
May 31, 2025 (estimated)
Completion
May 31, 2025 (estimated)
Last update
Feb 20, 2025

Study contacts

Oliver Findl
study chair · Vienna Institute for Research in Ocular Surgery

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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