Epiretinal MembranesNCT06830070
Subjective Pain Scoring for Subtenonal Anesthesia During Vitrectomy
An observational study of Epiretinal Membranes and Retinal Detachment, run by Prim. Prof. Dr. Oliver Findl, MBA at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epiretinal Membranes, Retinal Detachment, Full Thickness Macular Hole
- What is being tested?
- subjective pain score assessment
- How many people
- 70 participants
- Where
- 1 siteAustria
- Study dates
- 13 Dec 2023to 31 May 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients having undergone vitrectomy in subtenon´s anesthesia
Who may be able to join
- 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
Who cannot join
- Any of the following will exclude a subject from the study:
- Surgery in general anesthesia
- Questionnaire missing or incomplete
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- subjective pain score assessment
- Keywords
- subjective pain score, VAS, subtenonal anesthesia
- Medical subject headings
- Epiretinal Membrane, Retinal Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subjective pain score assessmentOther
a questionnaire assessing subjective pain during surgery, using the Visual Analogue Scale with values from 0 to 10
| Study group | Role | What they receive |
|---|---|---|
| vitreoretinal surface diseases | patients with the indications epiretinal membranes or full thickness macular holes are belonging to the Group of vitreoretnal surface diseases Receives: Other: subjective pain score assessment | |
| retinal detachment | patients with the indication retinal detachment are belonging to this group Receives: Other: subjective pain score assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: assessed within 24 hours sfter surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start13 Dec 2023
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Epiretinal MembranesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prim. Prof. Dr. Oliver Findl, MBA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery
- Investigators
- Oliver Findl, Study chair, Vienna Institute for Research in Ocular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06830070
- Sponsor's protocol ID
- SPS
- Status last verified
- Feb 2025
- First submitted
- 11 Feb 2025
- Last updated
- 20 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 18344970Lai 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 15808246Friedberg 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subjective Pain Scoring for Subtenonal Anesthesia During Vitrectomy
- ClinicalTrials.gov ID
- NCT06830070
- Acronym / sponsor ID
- SPS
- Keywords
- subjective pain score, VAS, subtenonal anesthesia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Prim. Prof. Dr. Oliver Findl, MBAUniversity, hospital or other
- Study start
- 13 Dec 2023 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 17 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitreoretinal surface diseases | – | Other: subjective pain score assessmentpatients with the indications epiretinal membranes or full thickness macular holes are belonging to the Group of vitreoretnal surface diseases |
| retinal detachment | – | Other: subjective pain score assessmentpatients with the indication retinal detachment are belonging to this group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients having undergone vitrectomy in subtenon´s anesthesia
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Surgery in general anesthesia
- Questionnaire missing or incomplete
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| subjective pain score assessmenta questionnaire assessing subjective pain during surgery, using the Visual Analogue Scale with values from 0 to 10 | Other | retinal detachment, vitreoretinal surface diseases |
Primary outcome
subjective pain score during surgery
Time frame: assessed within 24 hours sfter 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Background: PubMed 18344970El-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.
- Background: PubMed 15808246Lai 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.
- Background: PubMed 1845110Friedberg 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oliver Findl study chair
Vienna Institute for Research in Ocular Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epiretinal Membranes and Retinal Detachment, run by Prim. Prof. Dr. Oliver Findl, MBA at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
subjective pain score during surgery (time frame: assessed within 24 hours sfter surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06830070, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.