Health TrialsbyHealthPanel

Transconjunctival Versus Transcutaneous Betamethasone for Upper Eyelid Retraction in TED

ConditionThyroid Eye Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssiut University

About this trial

This randomized controlled trial aims to compare the efficacy and safety of transconjunctival versus transcutaneous perilevator betamethasone injection in reducing upper eyelid retraction in patients with thyroid eye disease.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

- Age 18 years or older

Clinical diagnosis of thyroid eye disease with stable thyroid function for at least 3 months

Unilateral or bilateral upper eyelid retraction with Margin Reflex Distance 1 greater than 4.5 mm in at least one eye

Thyroid eye disease duration less than 24 months

Disqualifiers

- Active sight-threatening thyroid eye disease requiring urgent decompression or systemic immunosuppression

Current or recent (within 3 months) systemic corticosteroids or other immunosuppressives for thyroid eye disease

Previous levator or Müller muscle surgery, botulinum toxin, or filler injection to the upper eyelid within 6 months

Contraindications to local steroid injection (active ocular infection, uncontrolled glaucoma, pregnancy or lactation)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Betamethasone

    Drug

    Betamethasone suspension 1 mL injected into the perilevator space.

Treatment groups

54 Participants
are divided into 2 treatment groups
Group A: Transconjunctival Perilevator InjectionExperimental treatment 1 intervention
Group B: Transcutaneous Perilevator InjectionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Margin Reflex Distance 1

Mean change in Margin Reflex Distance 1 (MRD1) in millimeters from baseline to 3 months after the first injection.

Time frame
At 3 months

Secondary outcomes

1

Proportion of eyes with effective response

Proportion of eyes achieving MRD1 ≤ 4.5 mm at 3 months.

Time frame
At 3 months
2

Mean number of injections required

Mean number of betamethasone injections required to reach target MRD1.

Time frame
At 12 months
3

Proportion of eyes with intraocular pressure elevation

Proportion of eyes with intraocular pressure ≥ 21 mmHg or increase ≥ 5 mmHg from baseline.

Time frame
At 12 months
4

Change in Graefe sign

Mean change in lid lag on downgaze (Graefe sign) in millimeters from baseline to 3 months.

Time frame
At 3 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: