Retinal DetachmentPhase 4NCT04701593
Using Triamcinolone Acetonide to Reduce Pain After Scleral Buckle Surgery
A Phase 4 study testing Triamcinolone Acetonide 40mg/mL in people with Retinal Detachment, run by Virginia Polytechnic Institute and State University at 1 site in United States.
Trial summary
PURPOSE: Scleral buckle surgery is a widely used ophthalmic surgery for the correction of rhegmatogenous retinal detachment. Studies suggest that eye pain is a common and underestimated occurrence after scleral buckle surgery, but as of yet, there is no definitive management method for reducing pain following scleral… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Retinal Detachment
- What is being tested?
- Triamcinolone Acetonide 40mg/mL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2020to 20 Oct 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must have rhegmatogenous retinal detachment and be scheduled to undergo scleral buckle surgery for correction
Who cannot join
- Advanced Glaucoma
- History of corticosteroid responsive elevation in IOP
- Allergy to Triamcinolone Acetonide or other corticosteroids
- Pre-existing chronic pain disorders
- Herpes zoster
- Prior corneal allograft
Show all 11Show fewer
- Allergy to local anesthetic or penicillin
- Patients unable to consent on own behalf
- Patients unable to communicate pain and nausea levels
- Pregnancy
- Incarceration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using Intraoperative Triamcinolone Acetonide Irrigation to Reduce Post-Operative Pain From Scleral Buckle Surgery
PURPOSE: Scleral buckle surgery is a widely used ophthalmic surgery for the correction of rhegmatogenous retinal detachment. Studies suggest that eye pain is a common and underestimated occurrence after scleral buckle surgery, but as of yet, there is no definitive management method for reducing pain following scleral buckle surgery. The investigators aim to control pain following scleral buckle surgery with sub-tenon's irrigation with triamcinolone acetonide at the time of surgery. Using a randomized prospective clinical study, the investigators test if this technique will reduce the pain, nausea/vomiting, and analgesic use caused by scleral buckle surgery.
METHODS: Forty-eight patients undergoing scleral buckle surgery will be randomized into two groups. The experimental group receives a sub-tenon irrigation of 1 cc 40mg/mL triamcinolone acetonide around the base of the scleral buckle (0.25 cc in each quadrant) at time of operation. The control group does not receive any triamcinolone irrigation. Pain scores are measured 1 day post-operatively via 11-pt numerical rating scale as the primary outcome. The nausea/vomiting score is measured 1 day post-operatively via standard 6-pt scale. Patients track pain medication use via pill count. Values will be measured again at 1-2-week and 6 months post-op.
- Conditions
- Retinal Detachment
- Being tested
- Triamcinolone Acetonide 40mg/mL
- Keywords
- Scleral Buckle, Triamcinolone Acetonide
- Medical subject headings
- Retinal Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone Acetonide 40mg/mLDrug
Also called Kenalog
Sub-tenon irrigation 1cc
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No additional drug given |
| Experimental (Triamcinolone Acetonide) | Experimental | receives a sub-tenon irrigation of 1 cc 40mg/mL triamcinolone acetonide around the base of the scleral buckle (0.25 cc in each quadrant) at time of operation Receives: Drug: Triamcinolone Acetonide 40mg/mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Operative Pain Day 1
11-point Numerical Rating Scale (0-10, 10 being highest level of pain)
Measured: 1 Day Post-Op
Secondary outcomes (2)
Post Operative Pain Week 1
11-point Numerical Rating Scale (0-10, 10 being highest level of pain)
Measured: 1 Week Post-Op
Pain Medication Use (Tylenol in mg)
Amount of Tylenol used (in mg) cumulatively over one week after the operation
Measured: Cumulative amount used was assessed at one week after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start3 Jan 2020
- Primary completion20 Oct 2022
- Study completion20 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Retinal DetachmentStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vishak J John, MD, Principal investigator, Virginia Tech, Vistar Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04701593
- Sponsor's protocol ID
- 19-377
- Status last verified
- Jun 2024
- First submitted
- 5 Jan 2021
- Last updated
- 23 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Intraoperative Triamcinolone Acetonide Irrigation to Reduce Post-Operative Pain From Scleral Buckle Surgery
- ClinicalTrials.gov ID
- NCT04701593
- Acronym / sponsor ID
- 19-377
- Conditions
- Retinal Detachment
- Keywords
- Scleral Buckle, Triamcinolone Acetonide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Study start
- 3 Jan 2020 (actual)
- Primary completion
- 20 Oct 2022 (actual)
- Study completion
- 20 Oct 2022 (actual)
- First posted
- 8 Jan 2021 (actual)
- Results
- Posted 27 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
PURPOSE: Scleral buckle surgery is a widely used ophthalmic surgery for the correction of rhegmatogenous retinal detachment. Studies suggest that eye pain is a common and underestimated occurrence after scleral buckle surgery, but as of yet, there is no definitive management method for reducing pain following scleral buckle surgery. The investigators aim to control pain following scleral buckle surgery with sub-tenon's irrigation with triamcinolone acetonide at the time of surgery. Using a randomized prospective clinical study, the investigators test if this technique will reduce the pain, nausea/vomiting, and analgesic use caused by scleral buckle surgery.
METHODS: Forty-eight patients undergoing scleral buckle surgery will be randomized into two groups. The experimental group receives a sub-tenon irrigation of 1 cc 40mg/mL triamcinolone acetonide around the base of the scleral buckle (0.25 cc in each quadrant) at time of operation. The control group does not receive any triamcinolone irrigation. Pain scores are measured 1 day post-operatively via 11-pt numerical rating scale as the primary outcome. The nausea/vomiting score is measured 1 day post-operatively via standard 6-pt scale. Patients track pain medication use via pill count. Values will be measured again at 1-2-week and 6 months post-op.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No additional drug given |
| Experimental (Triamcinolone Acetonide) | Experimental | Drug: Triamcinolone Acetonide 40mg/mLreceives a sub-tenon irrigation of 1 cc 40mg/mL triamcinolone acetonide around the base of the scleral buckle (0.25 cc in each quadrant) at time of operation |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient must have rhegmatogenous retinal detachment and be scheduled to undergo scleral buckle surgery for correction
Key exclusion criteria (11 listed)
- Advanced Glaucoma
- History of corticosteroid responsive elevation in IOP
- Allergy to Triamcinolone Acetonide or other corticosteroids
- Pre-existing chronic pain disorders
- Herpes zoster
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 |
|---|---|---|
| Triamcinolone Acetonide 40mg/mLAlso: KenalogSub-tenon irrigation 1cc | Drug | Experimental (Triamcinolone Acetonide) |
Primary outcome
Post Operative Pain Day 1
Time frame: 1 Day Post-Op
11-point Numerical Rating Scale (0-10, 10 being highest level of pain)
2 secondary outcomes
Post Operative Pain Week 1
Time frame: 1 Week Post-Op
Pain Medication Use (Tylenol in mg)
Time frame: Cumulative amount used was assessed at one week after operation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Retinal Detachment
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Stickler Syndrome Type 1, Stickler Syndrome Type 2
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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.
Vishak J John, MD principal investigator
Virginia Tech, Vistar Eye Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Triamcinolone Acetonide 40mg/mL in people with Retinal Detachment, run by Virginia Polytechnic Institute and State University at 1 site in United States.
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 1 inclusion and 11 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: finished, as of the sponsor's last update on 23 Jul 2024. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Post Operative Pain Day 1 (time frame: 1 Day Post-Op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jul 2024.