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The Therapeutic Effect of Dysthyroid Optic Neuropathy

Primary Purpose

Thyroid Eye Disease

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Orbital decompression combined with MPT
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Thyroid Eye Disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Zhongshan Opthalmic CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Orbital decompression combined MPT

Separate MPT

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

BCVA
best corrected visual acuity in logMAR
IOP
intraocular pressure in mmHg
proptosis
proptosis in mm
upper eyelid retraction
upper eyelid retraction in mm
CAS
clinical activity score

Secondary Outcome Measures

MD
mean deviation of visual field in dB
PSD
pattern standard deviation of visual field in dB

Full Information

First Posted
December 27, 2018
Last Updated
September 17, 2019
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT04096612
Brief Title
The Therapeutic Effect of Dysthyroid Optic Neuropathy
Official Title
The Therapeutic Effect of Dysthyroid Optic Neuropathy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Eye Disease

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Orbital decompression combined MPT
Arm Type
Experimental
Arm Description
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.
Arm Title
Separate MPT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Orbital decompression combined with MPT
Intervention Description
Orbital decompression combined with MPT
Primary Outcome Measure Information:
Title
BCVA
Description
best corrected visual acuity in logMAR
Time Frame
6 months
Title
IOP
Description
intraocular pressure in mmHg
Time Frame
6 months
Title
proptosis
Description
proptosis in mm
Time Frame
6 months
Title
upper eyelid retraction
Description
upper eyelid retraction in mm
Time Frame
6 months
Title
CAS
Description
clinical activity score
Time Frame
6 months
Secondary Outcome Measure Information:
Title
MD
Description
mean deviation of visual field in dB
Time Frame
6 months
Title
PSD
Description
pattern standard deviation of visual field in dB
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Zhongshan Opthalmic Center
City
Guangdong
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huasheng Yang, M.D.
Phone
+8620-87331539
Email
yanghs64@126.com

12. IPD Sharing Statement

Plan to Share IPD
Yes

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The Therapeutic Effect of Dysthyroid Optic Neuropathy

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