Modified Orbital Decompression in the Treatment of Moderate-to-severe Grave's Ophthalmopathy

NCT06588764 | Recruiting DMC

• 1 other identifier: yanghs20240821
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the efficacy and safety of modified deep lateral wall decompression and/or medial wall decompression for Moderate-to-severe Grave's Ophthalmopathy.

Conditions

Graves Ophthalmopathy; Surgery

Outcome Measures

Primary Outcomes (1)

• best corrected visual acuity (BCVA)

  Using Snellen scale, decimal fraction

  within 24 weeks of surgery

Secondary Outcomes (7)

• value of Hertel

  within 24 weeks of surgery

• the mean deviation value of visual field (VF)

  24 weeks after surgery

• pattern standard deviation value of visual field

  within 24 weeks of surgery

• the P100 latency of pattern visual evoked potential (PVEP)

  within 24 weeks of surgery

• N75-p100 amplitude of PVEP

  within 24 weeks of surgery

Study Arms (1)

Study group

EXPERIMENTAL

Modified deep lateral and/or medial wall decompression in Moderate-to-severe Graves' Orbitopathy

Procedure: modified deep lateral and/or medial wall decompression

Interventions

modified deep lateral and/or medial wall decompression PROCEDURE

Modified deep lateral orbital wall decompression is based on traditional outer wall decompression with combined abrasion of the deep outer orbital wall (including the greater pterygoid wing) to achieve adequate enlargement of the orbital cavity.

Study group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• EUGOGO/NOSPECS grade was moderate-to-severe thyroid associate ophthalmopathy;
• CAS≤3 score;
• stable thyroid function for at least 6 months;
• able and willing to participate in clinical trials and ensure regular follow-up;

You may not qualify if:

• any uncontrollable clinical problems (severe mental, neurological, cardiovascular, respiratory and other systemic diseases and malignant tumors);
• B-ultrasound or CT, MRI found other diseases causing exophthalmos (intraorbital space occupying lesion, inflammatory pseudotumor, neurofibroma, etc.);
• uveitis, glaucoma, high myopia, diabetic retinopathy and other eye diseases
• those who were considered by the researchers to be excluded

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Graves Ophthalmopathy

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Graves Disease; Exophthalmos; Orbital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Hua sheng Yang, M.D,PHD

CONTACT

+8620-87331539; yanghs64@162.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: September 19, 2024
• Study Start: September 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: January 1, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)