Thyroid Associated Orbitopathy with Ocular Hypertension
Conditions
Interventions
Optical coherence tomography (OCT) trend-based progression analysis (TPA)-guided group:Clinical examination, TAO examination, perimetry, OCT imaging, dry eye assessments
IOP-lowering treatment initiated to eyes with progressive retinal nerve fiber layer (RNFL) thinning
IOP-guided group:Clinical examination, TAO examination, perimetry, OCT imaging, dry eye assessments
IOP-lowering treatment initiated to eyes with IOP higher than 21mmHg in two consecutive visits
Sponsors
Research Office, Health Bureau
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Open angle on gonioscopy; 2. Visual acuity of at least 20/40 on Snellen Chart; 3. Diagnosed of thyroid associated orbitopathy (TAO), according to the Bartley and Gorman criteria; 4. Intraocular pressure (IOP) between 21 to 32mmHg (at primary position) without any glaucoma eye drops (OR patients on glaucoma medication who has a documented history of IOP elevation of > 21mmHg at the primary position); 5. Able to perform reliable Humphrey visual field (VF) test; 6. Able to take good quality ocular coherence tomography (OCT) images for retinal nerve fiber layers (RNFL), ganglion cell-inner plexiform layer (GCIPL), and RNFL optical texture analysis (ROTA), and 7. Eyes without functional and structural evidence of glaucomatous optic neuropathy (GON) – 2 reliable VF without VF defect, normal optic disc configuration without neuroretinal rim and/or RNFL in clinical examination, and normal OCT RNFL measurements without RNFL abnormalities (i.e., within the 95% normal ranges) in the RNFL thickness deviation map; 8. Eyes with early to moderate glaucoma with early glaucomatous VF defect (mean deviation [MD] of -0.01 to -6.00 dB); Note: while OCT forms an important part of our study, the assessment of optic nerve damage at baseline relies on clinical examination (direct observation under 90D lens) and not OCT.
Exclusion criteria
Exclusion criteria: 1. Eye with worse than moderate glaucomatous VF defect (MD worse than -12.01 dB) Note: glaucomatous VF defect is defined as: (1) Glaucoma hemifield test (GHT) outside normal limit, (2) Pattern standard deviation (PSD) with p-value = 3 non-edged points in the pattern deviation plot in a single hemifield with p-value = 20%; 3. Unable to take OCT images with good quality; 4. Patient with evidence of angle closure or extensive peripheral anterior synechiae (more than 180o); 5. Patients with evidence of dysthyroid optic neuropathy – clinical evidence or optic nerve compression; 6. Known history of glaucoma prior to the occurrence of TAO; 7. Other secondary causes of IOP elevation (e.g. uveitis, trauma, neovascular glaucoma, subluxed lens); 8. History of ocular or intraocular surgery except for orbital decompression, orbital irradiation, or uneventful cataract surgery >6 months prior to the recruitment; 9. Previous laser procedures (except YAG capsulotomy and retinal barrier laser >6 months prior to the recruitment); 10. Use of steroid in <1 month, and 11. One eye patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients requiring IOP-lowering treatment in 2 years; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of patients with VF progression;Total treatment cost;The dry eye-related parameters in 2 years; | — |
Countries
China
Contacts
Public ContactDr CHAN Pui Man Poemen
Department of Ophthalmology and Visual Sciences, the Chinese University of Hong Kong
Outcome results
None listed