Research

ITEDS TED Reliability and Validation Studies

1.  TED Ocular Ductions (VISA S) Reliability Study:

      status:  completed and published

 

2.  Exophthalmometry (VISA A) Reliability Study

      status:  completed and submitted for publication

3.  TED Inflammatory Signs (VISA I) Clinical Reliability Study

      status:  data accrual completed, in data analysis

4.  TED Inflammatory Signs (VISA I) Photographic Reliability Study

       Notification to invite ITEDS members to participate in this study will be posted soon.

 

 

ITEDS TED Randomized Controlled Trials

1.  ITEDS-S Study

ITEDS is overseeing the North American randomized, double-blinded, placebo-controlled trial of the efficacy of selenium supplementation in the treatment of mild Thyroid Eye Disease.  Eligible subjects should have had their TED disease for less than 1 year, should not have received selenium or corticosteroid therapy during this time, and should be willing to be followed for a one year follow-up period. Should you have an eligible patient who might wish to enroll, please contact us  to determine the nearest enrollment site.

 

2.  ITEDS CRISEPTED Study

Combined Radiotherapy and Intravenous Steroid for Early Progressive Thyroid Eye Disease  (CRISEPTED)

Purpose:  To demonstrate that combined XRT and iv CS is more effective than iv CS alone in preventing severe motility disruption (including strabismus and primary diplopia) and new-onset dysthyroid optic neuropathy in early progressive thyroid orbitopathy. 

Hypothesis:    Combined XRT and iv CS are more effective than iv CS alone in preventing motility problems (reduced field of single binocular vision, reduced ductions, strabismus and worsening diplopia) and in preventing new-onset dysthyroid optic neuropathy in patients with early progressive thyroid orbitopathy.

Method:        Multicentre, institutional based, randomized controlled trial                      Subjects:  100 patients randomized equally into two groups:

  1. Therapy:  iv MP 500 mg iv weekly for 6 weeks, then 250 mg iv weekly for 6 weeks          +  XRT 200 Rads both orbits x 10 doses
  2. Control:  Same iv MP dose                  + sham or no XRT (institutional dependent)

Inclusion criteria:

  1. Active TED:  Onset less than 6 months   AND:   Progressive with historic or measured worsening in one of VISA parameters in past 2 months
  2. Moderately severe TED (all of the following criteria must be met):             V:  No optic neuropathy   Inflammatory score >/= 4/10      S:   Any evidence of motility restriction subjectively or objectively but without primary diplopia

Exclusion criteria:        1.  Age < 35 yrs;   2.  Diabetes mellitus;   3.  Previous orbital surgery or radiotherapy for TED;      4.  Corticosteroid or immunotherapy within previous 2 months for TED;       5.  Unable or unwilling to provide informed consent

Main Outcome Measures:  

  1. Development of new onset DON
  2. Progression in motility dysfunction:  a)  Progression / improvement in diplopia scores at 6 months and 1 year;  b)  Progression / improvement in total duction scores for each eye at 6 months and 1 year     c)  Need for ultimate strabismus surgery at 1 year
  3. Number of patients escaping study because of development of DON requiring surgery or development of constant primary strabismus

Secondary Outcome Measures:       

  1. Change in VISA inflammatory/congestive scores at 6 and 12 month follow-ups
  2. GO QOL and TED QOL scores at baseline and 6 and 12 months post therapy
  3. Change in proptosis and lid retraction measurements at 6 and 12 month follow-ups
  4. Need for supplemental corticosteroid therapy beyond fixed treatment period

Escape criteria:

  1. Onset of DON with need for surgical decompression:  code is broken:  if no XRT given, consider administering at this point
  2. Progressive motility disruption with diplopia developing in straight gaze:       Break code and consider administering XRT if not administered

 

 

3.   CRISDON Study  (coordinated through Amsterdam Medical College)

Combined Radiotherapy and Intravenous Steroid for Dysthyroid Optic Neuropathy  (CRISDON)

 

Purpose:  To demonstrate that combined XRT and iv CS is more effective than iv CS alone in improving visual acuity in patients with DON.

Null-Hypothesis:  Combined XRT and iv CS are not more effective than iv CS alone in restoring visual functions in patients with DON.

Method:     Multicentre, institutional based, randomized controlled trial (see below)

Subjects:  40 patients randomized into two groups:

1.  Therapy:  iv MP 1000 mg on day 1,2 and 3 and repeated on day 10,11 and 12              +  XRT 200 Rads both orbits x 10 doses , start on day 1

2.  Control:  Same iv MP dose                   + sham XRT

Inclusion criteria:       Visual acuity ≤ 0,6 on the Snellen chart plus apical crowding (and no other explanation for visual loss)

Exclusion criteria:

  1. Previous orbital surgery or radiotherapy for TED
  2. Ocular pathology other than GO
  3. Diabetes mellitus
  4. Age < 35 years
  5. Unable or unwilling to provide informed consent

Main Outcome Measures:

  1. Improvement of visual acuity of ≥ 2 lines on the Snellen chart
  2. Number of patients escaping study because of need of orbital decompression for restoring vision

Secondary Outcome Measures:

  1. Change in Clinical Activity Score
  2. Change of  color vision
  3. Change of disc swelling
  4. Change of visual fields
  5. GO QOL and TED QOL scores at 3 months following therapy
  6. Need for supplemental immunosuppressive therapy beyond fixed treatment period