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The Therapeutic Effect of Dysthyroid Optic Neuropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04096612
Recruitment Status : Recruiting
First Posted : September 20, 2019
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
Huasheng Yang, Sun Yat-sen University

Brief Summary:
Thyroid associated ophthalmopathy (TAO) is a common autoimmune disorder. The pathogenesis of TAO is unclear, and studies found that T cell, B cell and monocytes, macrophages and mast cells are located in the orbital tissue of TAO. Dysthyroid optic neuropathy (DON) is the most serious complication of TAO, which can cause blurred vision, color vision and vision function damage, and affects the quality of life. Investigation of the therapeutic effect of orbital decompression may provide some clues to make the policy at treatment of DON. We explore the therapeutic effect of orbital decompression in patients with DON in both eyes.

Condition or disease Intervention/treatment Phase
Thyroid Eye Disease Procedure: Orbital decompression combined with MPT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: The Therapeutic Effect of Dysthyroid Optic Neuropathy
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Orbital decompression combined MPT
Orbital decompression was performed by the same doctor with rich clinical experience. MPT should be implemented in the patients with obvious thyroid disorder before orbital decompression surgery which should only be performed when thyroid function was stabilized. The surgery was performed under general anesthesia. An arcuate incision was made in the skin 2 mm below the lower eyelid margin, and the tissue under the incision were separated to the periorbita and orbital septum. Part of the medial orbital wall, inferior orbital wall and partial tissue of ethmoidal sinus were removed, and an appropriate amount of adipose tissue was excised. MPT was conducted after the surgery, at a dose of 1g methylprednisolone per day through intravenous injection for 3 consecutive days with a total amount of 3g methylprednisolone. After 3 days of intravenous injection of methylprednisolone, prednisone was orally taken by the patients at a dose of 30 mg/day which was gradually reduced.
Procedure: Orbital decompression combined with MPT
Orbital decompression combined with MPT

Experimental: Separate MPT
MPT was conducted after the surgery, at a dose of 1g methylprednisolone per day through intravenous injection for 3 consecutive days with a total amount of 3g methylprednisolone. After 3 days of intravenous injection of methylprednisolone, prednisone was orally taken by the patients at a dose of 30 mg/day which was gradually reduced.
Procedure: Orbital decompression combined with MPT
Orbital decompression combined with MPT




Primary Outcome Measures :
  1. BCVA [ Time Frame: 6 months ]
    best corrected visual acuity in logMAR

  2. IOP [ Time Frame: 6 months ]
    intraocular pressure in mmHg

  3. proptosis [ Time Frame: 6 months ]
    proptosis in mm

  4. upper eyelid retraction [ Time Frame: 6 months ]
    upper eyelid retraction in mm

  5. CAS [ Time Frame: 6 months ]
    clinical activity score


Secondary Outcome Measures :
  1. MD [ Time Frame: 6 months ]
    mean deviation of visual field in dB

  2. PSD [ Time Frame: 6 months ]
    pattern standard deviation of visual field in dB



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

- Ability to perform visual fields and VEP examination Without any serious systemic diseases Without any surgery on eyes in six months

Exclusion Criteria:

- With any serious systemic diseases With any surgery on eyes in six months


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04096612


Locations
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China, Guangdong
Zhongshan Opthalmic Center Recruiting
Guangdong, Guangdong, China, 510060
Contact: Huasheng Yang, M.D.    +8620-87331539    yanghs64@126.com   
Sponsors and Collaborators
Sun Yat-sen University

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Responsible Party: Huasheng Yang, Clinical Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT04096612    
Other Study ID Numbers: yanghs2018
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Optic Nerve Diseases
Graves Ophthalmopathy
Eye Diseases
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases, Hereditary
Graves Disease
Exophthalmos
Orbital Diseases
Genetic Diseases, Inborn
Goiter
Thyroid Diseases
Endocrine System Diseases
Hyperthyroidism
Autoimmune Diseases
Immune System Diseases