Treatment of Upper Lid Retraction Related to Thyroid-associated Ophthalmopathy: A comparative Study Between Subconjunctival Triamcinolone and Botulinum Toxin Injection

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20260701006

Enrollment

Registered

2026-07-01

Start date

2025-07-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Upper eyelid retraction related to Thyroid-associated Ophthalmopathy or Thyroid Eye Disease. upper lid retraction, thyroid eye disease, Thyroid-associated Ophthalmopathy, triamcinolone, Botulinum Toxin.

Interventions

Eyes received a single subconjunctival injection of triamcinolone acetonide (40 mg/mL) at a total dose of 20 mg (0.5 mL). The dose was divided equally and injected into the medial subconjunctival spac

Active Comparator Drug,Active Comparator Drug

Triamcinolone Group,Botulinum Toxin Group

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Adult patients aged 18 to 80 years 2. Patients diagnosed with mild or moderate-to-severe Thyroid Eye Disease (TED) or Thyroid-associated Ophthalmopathy (TAO). 3. Clinical Activity Score (CAS) less than 4. 4. Presenting with unilateral or bilateral upper eyelid retraction. 5. Duration of upper eyelid retraction is less than or equal to 18 months.

Exclusion criteria

Exclusion criteria: 1. Active thyroid eye disease or sight-threatening thyroid eye disease. 2. Presence of extraocular muscle restriction or diplopia. 3. Hypertropia or hypotropia. 4. Infectious keratitis. 4. Pregnancy. 5. Prior treatment for thyroid eye disease. 6. Known hypersensitivity to triamcinolone acetonide or botulinum toxin A. 7. Baseline intraocular pressure (IOP) greater than 24 mmHg or known glaucoma.

Design outcomes

Primary

Measure	Time frame
Change in Margin Reflex Distance 1 (MRD1) Baseline, 1 week, 1 month, and 3 months post-injection Change in Margin Reflex Distance 1 (MRD1)	—

Secondary

Measure	Time frame
Changes in palpebral fissure height (PF) across central, medial, and lateral dimensions Baseline, 1 week, 1 month, and 3 months post-injection Changes in palpebral fissure height (PF) across central, medial, and lateral dimensions,Incidence of adverse events and drug-related complications including intraocular pressure changes and temporary ptosis Baseline, 1 week, 1 month, and 3 months post-injection Incidence of adverse events and drug-related complications including intraocular pressure changes and temporary ptosis	—

Measure

Time frame

Changes in palpebral fissure height (PF) across central, medial, and lateral dimensions Baseline, 1 week, 1 month, and 3 months post-injection Changes in palpebral fissure height (PF) across central, medial, and lateral dimensions,Incidence of adverse events and drug-related complications including intraocular pressure changes and temporary ptosis Baseline, 1 week, 1 month, and 3 months post-injection Incidence of adverse events and drug-related complications including intraocular pressure changes and temporary ptosis

—

Countries

Thailand

Contacts

Public ContactThanachot Nacharoenkul

Department of Ophthalmology, Faculty of Medicine Vajira Hospital, Navamindradhiraj University

Thanachot.nac@gmail.com66870686999

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026