NCT04096612

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

December 27, 2018

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
9 months until next milestone

First Posted

Study publicly available on registry

September 20, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

September 20, 2019

Status Verified

September 1, 2019

Enrollment Period

3 years

First QC Date

December 27, 2018

Last Update Submit

September 17, 2019

Conditions

Thyroid Eye Disease

Outcome Measures

Primary Outcomes (5)

  • BCVA

    best corrected visual acuity in logMAR

    6 months

  • IOP

    intraocular pressure in mmHg

    6 months

  • proptosis

    proptosis in mm

    6 months

  • upper eyelid retraction

    upper eyelid retraction in mm

    6 months

  • CAS

    clinical activity score

    6 months

Secondary Outcomes (2)

  • MD

    6 months

  • PSD

    6 months

Study Arms (2)

Orbital decompression combined MPT

EXPERIMENTAL

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

Separate MPT

EXPERIMENTAL

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

Interventions

Orbital decompression combined with MPTPROCEDURE

Orbital decompression combined with MPT

Orbital decompression combined MPTSeparate MPT

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Opthalmic Center

Guangdong, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Graves Ophthalmopathy

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryEye DiseasesGraves DiseaseExophthalmosOrbital DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGoiterThyroid DiseasesEndocrine System DiseasesHyperthyroidismAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

December 27, 2018

First Posted

September 20, 2019

Study Start

January 1, 2016

Primary Completion

December 31, 2018

Study Completion

December 31, 2019

Last Updated

September 20, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations

CN(1)