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NCT Number: NCT06588764

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

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

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Location status: Recruiting

Location contact

Huasheng Yang, M.D, PHD

CONTACT

[email protected]

+8613602721743

About this study

The purpose of the study is to evaluate the effectiveness and complications of modified deep lateral wall decompression and medial wall decompression, in order to develop a standardized technical approach to the treatment of Moderate-to-severe Grave's Ophthalmopathy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. best corrected visual acuity (BCVA)

    Time frame: within 24 weeks of surgery

    Using Snellen scale, decimal fraction

Secondary outcomes

  1. value of Hertel

    Time frame: within 24 weeks of surgery

    as measured using a Hertel exophthalmometer, to describe the degree of exophthalmos

  2. the mean deviation value of visual field (VF)

    Time frame: 24 weeks after surgery

    The mean deviation (MD) gives an overall value of the total amount of visual field loss, with normal values typically within 0dB to -2dB. The mean deviation value of visual field (VF) was examined by HFA (Humphrey II, Carl-Zeiss, Dublin, CA).

  3. pattern standard deviation value of visual field

    Time frame: within 24 weeks of surgery

    The pattern standard deviation (PSD) can filter out the decrease in visual acuity caused by turbidity of the dioptric interstitial. The pattern standard deviation (PSD) was examined by HFA (Humphrey II, Carl-Zeiss, Dublin, CA).

  4. the P100 latency of pattern visual evoked potential (PVEP)

    Time frame: within 24 weeks of surgery

    The visual stimulus was a pattern reversal checkerboard displayed on a black and white monitor placed 105 cm from the patient. The wave latency of P100 was recorded.

  5. N75-p100 amplitude of PVEP

    Time frame: within 24 weeks of surgery

    Wave amplitude difference between N75-P100 peak and trough.

  6. clinical activity score (CAS)

    Time frame: within 24 weeks of surgery

    The CAS is a 7-item description of clinical activity, including: 1. Spontaneous orbital pain; 2. Gaze evoked orbital pain; 3. Eyelid swelling that is considered to be due to active (inflammatory phase) thyroid eye disease/ Graves' Ophthalmopathy or Orbitopathy (TED/GO); 4. Eyelid erythema; 5. Conjunctival redness that is considered to be due to active (inflammatory phase) TED/GO (ignore "equivocal" redness); 6. Chemosis; 7. Inflammation of caruncle or plica.

  7. volume of adipose tissue

    Time frame: during the surgery

    Prolapsing extraconal and intraconal orbital fat were resected from the orbital margin deep into the intraconal apex. The desired volume of adipose tissue was measured intraoperatively using 5 or 10 cc syringe.

Study contacts

Contact information is provided by the study sponsor or research team.

Hua sheng Yang, M.D,PHD

CONTACT

[email protected]

+8620-87331539

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

Modified Deep Lateral Wall Decompression and/or Deep Medial Wall Decompression for Moderate-to-severe Grave's Ophthalmopathy: a Prospective Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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