The Therapeutic Effect of Dysthyroid Optic Neuropathy

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Primary Purpose

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Orbital decompression combined with MPT

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

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

NCT ID

NCT04096612

First Posted

December 27, 2018

Last Updated

September 17, 2019

Sponsor

Sun Yat-sen University

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

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

Thyroid Eye Disease

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial