Thyroid Eye Disease, TEDTREAT-OTNCT07471997
Triamcinolone Acetonide Injection for Upper Eyelid Retraction in Thyroid Eye Disease
A study testing Triamcinolone Acetonide in people with Thyroid Eye Disease, TED, run by Instituto de Oftalmología Fundación Conde de Valenciana at 1 site in Mexico.
Trial summary
Thyroid eye disease frequently causes upper eyelid retraction, which can lead to ocular surface complications and cosmetic concerns. Several medical and surgical treatments have been proposed; however, minimally invasive therapies remain of interest. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Eye Disease, TED
- What is being tested?
- Triamcinolone Acetonide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteMexico
- Study dates
- 20 Jun 2024to 20 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Male or female participants aged 18 years or older.
- Diagnosis of thyroid eye disease.
- Presence of upper eyelid retraction defined as margin reflex distance 1 (MRD1) ≥ 4.5 mm.
- Clinical Activity Score (CAS) lower than 3 points.
- Ability and willingness to provide written informed consent.
Who cannot join
- Previous or current systemic corticosteroid treatment during the study period.
- Active thyroid eye disease with Clinical Activity Score (CAS) ≥ 3.
- Other causes of eyelid retraction.
- Need for urgent surgical management.
- Known allergy to triamcinolone acetonide.
- Known steroid responders.
- Diagnosis of advanced primary or secondary glaucoma according to Hodapp-Parrish-Anderson criteria.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto de Oftalmologia F.A.P. Conde de Valenciana, I.A. P.
Mexico City
About this study
Official title: Efficacy of Transseptal and Transconjunctival Triamcinolone Acetonide Injection for the Treatment of Upper Eyelid Retraction in Patients With Thyroid Eye Disease
Thyroid eye disease frequently causes upper eyelid retraction, which can lead to ocular surface complications and cosmetic concerns. Several medical and surgical treatments have been proposed; however, minimally invasive therapies remain of interest.
This study evaluates the efficacy of local triamcinolone acetonide injection administered through transconjunctival and transseptal routes for the treatment of upper eyelid retraction in patients with inactive thyroid eye disease.
Patients with thyroid eye disease and upper eyelid retraction were treated with a combined subconjunctival and transcutaneous injection of triamcinolone acetonide. Clinical measurements including margin reflex distance 1 (MRD1), palpebral fissure height, visual acuity, intraocular pressure, and Clinical Activity Score (CAS) were evaluated before treatment and one month after intervention.
Read the detailed description
Thyroid eye disease (TED) is an autoimmune inflammatory disorder characterized by orbital tissue expansion and eyelid abnormalities. Upper eyelid retraction is the most common clinical sign and may cause ocular exposure, discomfort, and significant cosmetic concerns.
The pathophysiology of eyelid retraction in TED involves inflammation and fibrosis of eyelid retractors, including the levator palpebrae superioris and Müller muscle. Although surgical correction is effective, it is generally reserved for the inactive stage of the disease. Therefore, medical therapies aimed at reducing inflammation and modulating eyelid retractor function have been explored.
Triamcinolone acetonide is a synthetic corticosteroid with potent anti-inflammatory effects and prolonged local action due to its depot formulation. Local administration may reduce inflammation of eyelid tissues while minimizing systemic adverse effects.
This prospective interventional study evaluates the efficacy of triamcinolone acetonide administered through combined transconjunctival and transseptal injections in patients with upper eyelid retraction secondary to inactive thyroid eye disease.
Participants were recruited from the Thyroid Clinic at the Conde de Valenciana Institute of Ophthalmology. Each patient received a subconjunctival injection of triamcinolone acetonide above the superior tarsal border and a transcutaneous injection into the upper eyelid. Clinical parameters including margin reflex distance 1 (MRD1), palpebral fissure height, visual acuity, intraocular pressure, eyelid crease height, and Clinical Activity Score were recorded at baseline and one month after treatment.
The primary objective of the study is to evaluate changes in MRD1 after treatment. Secondary outcomes include changes in palpebral fissure height, intraocular pressure, visual acuity, and clinical activity score. Safety outcomes include the evaluation of adverse effects associated with periocular corticosteroid injection.
- Conditions
- Thyroid Eye Disease, TED
- Being tested
- Triamcinolone Acetonide
- Keywords
- Upper Eyelid Retraction, Oculoplastic Surgery, Triamcinolone Acetonide
- Medical subject headings
- Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone AcetonideDrug
Triamcinolone acetonide administered as a subconjunctival injection (0.3 mL; 12 mg) above the superior tarsal border combined with a transseptal upper eyelid injection (0.2 mL; 8 mg).
| Study group | Role | What they receive |
|---|---|---|
| Triamcinolone Injection | Experimental | Participants with upper eyelid retraction secondary to thyroid eye disease receive local triamcinolone acetonide injection administered through combined transconjunctival and transseptal approaches. Receives: Drug: Triamcinolone Acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Margin Reflex Distance 1 (MRD1)
Evaluation of the change in upper eyelid position measured as Margin Reflex Distance 1 (MRD1), defined as the distance from the corneal light reflex to the upper eyelid margin. Measurements are obtained before treatment and one month after triamcinolone acetonide injection.
Measured: Baseline and 1 Month After Treatment
Secondary outcomes (2)
Change in Palpebral Fissure Height
Evaluation of the change in palpebral fissure height, defined as the vertical distance between the upper and lower eyelid margins, measured at baseline and one month after triamcinolone acetonide injection.
Measured: Baseline and 1 Month After Treatment
Change in Intraocular Pressure
Evaluation of the change in intraocular pressure measured in mmHg before treatment and after triamcinolone acetonide injection as a safety outcome.
Measured: Baseline, 1 Week, and 1 Month After Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start20 Jun 2024
- Primary completion20 Feb 2025
- Study completion20 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Eye Disease, TEDStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants with upper eyelid retraction secondary to thyroid eye disease receive a single treatment consisting of combined transconjunctival and transseptal triamcinolone acetonide injection. Clinical measurements are evaluated before treatment and one month after the intervention to assess changes in eyelid position and ocular parameters.
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Oftalmología Fundación Conde de Valenciana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07471997
- Sponsor's protocol ID
- OT-TRIAMCINOLONE-2024
- Acronym
- TREAT-OT
- Status last verified
- Oct 2026
- First submitted
- 7 Mar 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Transseptal and Transconjunctival Triamcinolone Acetonide Injection for the Treatment of Upper Eyelid Retraction in Patients With Thyroid Eye Disease
- ClinicalTrials.gov ID
- NCT07471997
- Acronym / sponsor ID
- TREAT-OT / OT-TRIAMCINOLONE-2024
- Conditions
- Thyroid Eye Disease, TED
- Keywords
- Upper Eyelid Retraction, Oculoplastic Surgery, Triamcinolone Acetonide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Instituto de Oftalmología Fundación Conde de ValencianaUniversity, hospital or other
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 20 Feb 2025 (actual)
- Study completion
- 20 Feb 2025 (actual)
- First posted
- 16 Mar 2026 (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.
Thyroid eye disease frequently causes upper eyelid retraction, which can lead to ocular surface complications and cosmetic concerns. Several medical and surgical treatments have been proposed; however, minimally invasive therapies remain of interest.
This study evaluates the efficacy of local triamcinolone acetonide injection administered through transconjunctival and transseptal routes for the treatment of upper eyelid retraction in patients with inactive thyroid eye disease.
Patients with thyroid eye disease and upper eyelid retraction were treated with a combined subconjunctival and transcutaneous injection of triamcinolone acetonide. Clinical measurements including margin reflex distance 1 (MRD1), palpebral fissure height, visual acuity, intraocular pressure, and Clinical Activity Score (CAS) were evaluated before treatment and one month after intervention.
Detailed description
Thyroid eye disease (TED) is an autoimmune inflammatory disorder characterized by orbital tissue expansion and eyelid abnormalities. Upper eyelid retraction is the most common clinical sign and may cause ocular exposure, discomfort, and significant cosmetic concerns.
The pathophysiology of eyelid retraction in TED involves inflammation and fibrosis of eyelid retractors, including the levator palpebrae superioris and Müller muscle. Although surgical correction is effective, it is generally reserved for the inactive stage of the disease. Therefore, medical therapies aimed at reducing inflammation and modulating eyelid retractor function have been explored.
Triamcinolone acetonide is a synthetic corticosteroid with potent anti-inflammatory effects and prolonged local action due to its depot formulation. Local administration may reduce inflammation of eyelid tissues while minimizing systemic adverse effects.
This prospective interventional study evaluates the efficacy of triamcinolone acetonide administered through combined transconjunctival and transseptal injections in patients with upper eyelid retraction secondary to inactive thyroid eye disease.
Participants were recruited from the Thyroid Clinic at the Conde de Valenciana Institute of Ophthalmology. Each patient received a subconjunctival injection of triamcinolone acetonide above the superior tarsal border and a transcutaneous injection into the upper eyelid. Clinical parameters including margin reflex distance 1 (MRD1), palpebral fissure height, visual acuity, intraocular pressure, eyelid crease height, and Clinical Activity Score were recorded at baseline and one month after treatment.
The primary objective of the study is to evaluate changes in MRD1 after treatment. Secondary outcomes include changes in palpebral fissure height, intraocular pressure, visual acuity, and clinical activity score. Safety outcomes include the evaluation of adverse effects associated with periocular corticosteroid injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants with upper eyelid retraction secondary to thyroid eye disease receive a single treatment consisting of combined transconjunctival and transseptal triamcinolone acetonide injection. Clinical measurements are evaluated before treatment and one month after the intervention to assess changes in eyelid position and ocular parameters.
| Arm | Type | Receives |
|---|---|---|
| Triamcinolone Injection | Experimental | Drug: Triamcinolone AcetonideParticipants with upper eyelid retraction secondary to thyroid eye disease receive local triamcinolone acetonide injection administered through combined transconjunctival and transseptal approaches. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female participants aged 18 years or older.
- Diagnosis of thyroid eye disease.
- Presence of upper eyelid retraction defined as margin reflex distance 1 (MRD1) ≥ 4.5 mm.
- Clinical Activity Score (CAS) lower than 3 points.
- Ability and willingness to provide written informed consent.
Key exclusion criteria (7 listed)
- Previous or current systemic corticosteroid treatment during the study period.
- Active thyroid eye disease with Clinical Activity Score (CAS) ≥ 3.
- Other causes of eyelid retraction.
- Need for urgent surgical management.
- Known allergy to triamcinolone acetonide.
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 AcetonideTriamcinolone acetonide administered as a subconjunctival injection (0.3 mL; 12 mg) above the superior tarsal border combined with a transseptal upper eyelid injection (0.2 mL; 8 mg). | Drug | Triamcinolone Injection |
Primary outcome
Change in Margin Reflex Distance 1 (MRD1)
Time frame: Baseline and 1 Month After Treatment
Evaluation of the change in upper eyelid position measured as Margin Reflex Distance 1 (MRD1), defined as the distance from the corneal light reflex to the upper eyelid margin. Measurements are obtained before treatment and one month after triamcinolone acetonide injection.
2 secondary outcomes
Change in Palpebral Fissure Height
Time frame: Baseline and 1 Month After Treatment
Change in Intraocular Pressure
Time frame: Baseline, 1 Week, and 1 Month After Treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: Yes
Related trials for Thyroid Eye Disease, TED
RecruitingObservational study
Early Risk Stratification of Thyroid Eye Disease in Newly Diagnosed Graves' Disease
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RecruitingPhase 1
Evaluation of ETHY-001 for Safety, Tolerability, and Clinical Activity in Thyroid Eye Disease
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Not yet recruitingPhase 2
Prophylactic Treatment of Graves Ophthalmopathy (GO) in Newly Diagnosed Graves' Disease (GD) With Atorvastatin (ATORGO)
Graves Disease, Graves Disease (Basedow's Disease)
RecruitingPhase 3
Study to Assess Linsitinib in Participants With Moderate to Severe Active Thyroid Eye Disease (TED)
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triamcinolone Acetonide in people with Thyroid Eye Disease, TED, run by Instituto de Oftalmología Fundación Conde de Valenciana at 1 site in Mexico.
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 5 inclusion and 7 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 16 Oct 2026. 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 Mexico. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Margin Reflex Distance 1 (MRD1) (time frame: Baseline and 1 Month After Treatment). 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 16 Oct 2026.